Medline Industries, Inc.

Difficult Airway Tray W/O Cook

Registry build 21.09.26
55manufacturers in China registered for this device type
3,457catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (18), Guangdong (18), Jiangsu (5). 18 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAI
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Zhejiang Haisheng Medical Device Co., Ltd. Shaoxing Zhejiang Contract manufacturer 21
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
Ningbo Great Mountain Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 12
Ningbo Shengyurui Medical Appliance Co. Ningbo Zhejiang Contract manufacturer 11
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Flying Tooling Engineering Limited Dongguan Guangdong Contract manufacturer 9
Hangzhou Formed Medical Devices Co., Ltd. Hangzhou Zhejiang Contract manufacturer 9

Showing 12 of 55. All 55 manufacturers in China registered for Circuit, Breathing (W Connector, Adaptor, Y Piece)

Record

Regulatory record for Medline Industries, Inc.
Listed by Medline Industries, Inc., United States
FDA product code CAI
Device type Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device class Class 1
Regulation 21 CFR 868.5240
Premarket notification Exempt
Record published 2018-08-28
Record revised 2023-08-31 (version 10)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date
Packaging Case of 20, case of 40, case of 10, case of 6, case of 15, case of 50
Distribution end date 2021-07-21
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Medline Industries, Inc.
Catalogue number Size Status
301402-1 In distribution
DYNJAA0379A In distribution
DYNJAA10718 In distribution
DYNJAA9776B In distribution
DYNJAA10670 In distribution
DYNJAA10393 In distribution
DYNJAA0427 In distribution
DYNJAA10315 In distribution
DYNJAP9986 In distribution
B4C112C005 In distribution
ACC010757A In distribution
72300-1-30 In distribution
ACC010578 In distribution
DYNJAA10924 In distribution
DYNJAA10954 In distribution
DYNJAA0411 In distribution
DYNJAA10860 In distribution
DYNJAA6608B In distribution
DYNJAA6652 In distribution
DYNJAA9915C In distribution
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DYNJAA275 In distribution
DYNJAAF6522D In distribution
DYNJAA10991 In distribution
DYNJ61476A In distribution
DYNJAP10069A In distribution
DYNJAAF6573 In distribution
DYNJAAF6591 In distribution
DYNJAA9933A In distribution
DYNJAA9757A In distribution
DYNJAP10071 In distribution
DYNJAA11117A In distribution
DYNJAP6190 In distribution
DYNJAP10026 In distribution
DYNJAA10076A In distribution
DYNJAP10095 In distribution
DYNJAAF6655 In distribution
DYNJAA10547 In distribution
DYNJ39985B In distribution
DYNJAA6646A In distribution
DYNJAAF6556B In distribution
DYNJAA10651A In distribution
DYNJAAF6385C In distribution
DYNJAA10627A In distribution
5001B In distribution
DYNJAP10137 In distribution
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DYNJAA10599 In distribution
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96F1013-1 In distribution
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DYNJAP10049A In distribution
DYNJAA10790 In distribution
387901 In distribution
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DYNJAA10634B In distribution
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ACC010379A In distribution
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DYNJAA4799A In distribution
DYNJAAF6515 In distribution
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DYNDA1991B In distribution
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DYNJAA10434D In distribution
DYNJA724951C In distribution
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18-2002 In distribution
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225-4458-300 In distribution
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DYNJRA1119 In distribution
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DYNJ34184 In distribution
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2700-205 In distribution
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ACC010335B In distribution
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225-3027-300 In distribution
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ACC010757B In distribution
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ACC010917 In distribution
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401013-1 In distribution
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PHS41720G In distribution
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144S1002-1-30 In distribution
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ACC010540A In distribution
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601401-1 In distribution
ACC010434B In distribution
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DYNJAP6180 In distribution
DYNJAAF6741 In distribution
DYNJAP10085 In distribution
DYNJAA10035A In distribution
DYNJAA10672 In distribution
DYNJAA0329C In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Vital Signs™ Airlife, Inc. 1,018
Hudson RCI Teleflex Medical LLC 176
Vital Signs™ AirLife Finland Oy 143
Universal F2®ANESTHESIA Breathing Circuit King Systems Corporation. 133
Universal FLEX2®BREATHING Circuit King Systems Corporation. 123
Adult Ultra Flex®anesthesia Breathing Circuit King Systems Corporation. 111
Portex ICU Medical, Inc 95
AincA® Anesthesia Associates, Inc. 76
Medline/MMS Sales Medline Industries, Inc. 73
Pediatric Ultra Flex®anesthesia Breathing Circuit King Systems Corporation. 71
Vital Signs™ Vyaire Medical, Inc. 70
PED F2® Pediatricanesthesia Breathing Circuit King Systems Corporation. 56

Showing 12 of 522. All products under Circuit, Breathing (W Connector, Adaptor, Y Piece)

Recalls Naming This Product

27 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Medline Industries, Inc.
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Medline Industries, LP – Northfield UDI-DI 2026-08-11 Not classified Nonconforming Material/Component The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products 12 kits
Medline Industries, LP – Northfield UDI-DI 2026-06-12 Class II Nonconforming Material/Component The kits contain BD ChloraPrep Clear – 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is co 104 kits
Medline Industries, LP – Northfield UDI-DI 2026-05-28 Class II Process change control Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen d 9,272 kits
Medline Industries, LP – Northfield UDI-DI 2026-05-28 Class II Under Investigation by firm Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in i 1400 kits
Medline Industries, LP – Northfield UDI-DI 2026-05-06 Class I Nonconforming Material/Component The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA i 227 units
Medline Industries, LP – Northfield UDI-DI 2026-04-10 Class I Component design/selection Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complai 1100 kits
Medline Industries, LP – Northfield UDI-DI 2026-03-19 Class II Under Investigation by firm During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. 306 kits
Medline Industries, LP – Northfield UDI-DI 2026-03-19 Class II Under Investigation by firm During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. 413 kits
Medline Industries, LP – Northfield UDI-DI 2026-02-16 Class II Under Investigation by firm Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragmen 14,379 kits total
Medline Industries, LP – Northfield UDI-DI 2026-01-07 Class II Under Investigation by firm Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have 551 units
Medline Industries, LP – Northfield UDI-DI 2026-01-07 Class II Process control Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have 599 units
Medline Industries, LP – Northfield UDI-DI 2025-12-24 Class II Under Investigation by firm A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to par 130
Medline Industries, LP – Northfield UDI-DI 2025-12-24 Class II Packaging change control Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. 120 kits
Medline Industries, LP – Northfield UDI-DI 2025-11-26 Class II Nonconforming Material/Component Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions. 10 units
Medline Industries, LP – Northfield UDI-DI 2025-11-26 Class II Nonconforming Material/Component Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions. 633 units
Medline Industries, LP – Northfield UDI-DI 2025-11-26 Class II Nonconforming Material/Component Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions. 32 units
Medline Industries, LP – Northfield UDI-DI 2025-10-10 Class I Nonconforming Material/Component Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120″ expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may resu 96,406 total units
Medline Industries, LP – Northfield UDI-DI 2025-07-25 Class I Component design/selection Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended. 2520 units
Medline Industries, LP – Northfield UDI-DI 2025-02-24 Class I Process change control Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical. 1550 units
Medline Industries, LP – Northfield UDI-DI 2025-01-09 Class II Under Investigation by firm Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced. 70 kits
Medline Industries, LP – Northfield UDI-DI 2024-09-04 Class II Under Investigation by firm It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. 15 units
Medline Industries, LP – Northfield UDI-DI 2024-06-27 Class II Process control Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suc 29,585 units
Medline Industries, LP – Northfield UDI-DI 2024-06-18 Class II Process change control A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use 315 units
Medline Industries, LP – Northfield UDI-DI 2024-03-14 Class II Process control Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails. 7,673 total non-sterile kits
Medline Industries, LP – Northfield UDI-DI 2024-02-26 Class I Under Investigation by firm Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult 168,632 tubes and 13,092 kits
Medline Industries, LP – Northfield UDI-DI 2023-05-18 Class II Device Design Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. 100 units
Medline Industries, LP – Northfield UDI-DI 2022-11-17 Class II Device Design Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. 48 cases (96 units)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer