What is FDA product code LRS?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

General Hospital › TherapeuticI.V. Start Kit

IV Start Kit

Name: IV Start Kit
Brand: IV Start Kit

IV Start Kit is a single-use, disposable procedure packs with various combination of components, such as adhesive dressing, underpad, gauze, label, tourniquet, and sterile field. The…

Registry build 21.09.26

IV Start Kit is a single-use, disposable procedure packs with various combination of components, such as adhesive dressing, underpad, gauze, label, tourniquet, and sterile field. The procedure packs are widely used by clinical professionals using aseptic technique for patient requires Intravenous Cannula Insertion.

7manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (3), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LRS
Manufacturer	City	Province	Registered as	Device types
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Amsino Medical (Kunshan) Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	53
Hubei Lanbin Medical Group Co., Ltd.	Xiaogan	Hubei	Contract manufacturer	33
Zibo Qichuang Medical Products Co., Ltd.	Zibo	Shandong	Manufacturer	27
Yafho BIO-Technology Co., Ltd.	Guangzhou	Guangdong	Manufacturer	14
Xiamen ANK Hygiene Care Product Co., Ltd.	Xiamen	Fujian	Manufacturer	11

Record

Regulatory record for IV Start Kit
Listed by	ITL Asia Pacific SDN BHD, Malaysia
FDA product code	LRS
Device type	I.V. Start Kit
Device class	Class 2
Regulation	21 CFR 880.5200
Establishment	Contract manufacturer, Manufacturer
Premarket notification	Exempt
Record published	2023-06-28
Record revised	2023-07-14 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Keep Dry; Special storage condition: Keep Away from Direct Sunlight
Packaging	Outer, carton of 130

Catalogue Numbers

Catalogue numbers for IV Start Kit
Catalogue number	Size	Status
IVSK100		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	1,066
Centurion	Centurion Medical Products Corporation	886
Medline Industries, Inc.	Medline Industries, Inc.	740
Medline	Medline Industries, Inc.	621
Medical Action Industries	Medical Action Industries, Inc.	512
Curaplex	Bound Tree Medical, LLC	149
Motion Medical Distributing	Haslam Medical, Inc.	118
LSL Healthcare	Lsl Industries, Inc.	83
Vygon	Vygon Corp.	76
Trinity Sterile, Inc.	Trinity Sterile, Inc.	63
MediChoice	Owens & Minor Distribution, Inc.	46
McKesson	Mckesson Medical-Surgical Inc.	21

Showing 12 of 58. All products under I.V. Start Kit

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.