Cardinal Health

Argyle Flexible Yankauer Sump Tip, Regular Capacity with Vent

Registry build 21.09.26
30manufacturers in China registered for this device type
310catalogue numbers in this listing
5recalls on this code

Who Else Makes It

Concentrated in Zhejiang (8), Jiangsu (7), Guangdong (7). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GCX
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Dongguan Junhai Medical Device Co., Ltd. Dong Guang Guangdong Contract manufacturer 9
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Infitek Co., Ltd. Shanghai Shanghai Manufacturer 49
Rusun Medical Co., Ltd. Yichun Jiangxi Manufacturer 37
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Tianjin Tairuibosi Medical Appliance Co., Ltd. Tianjin Tianjin Private-label distributor 30

Showing 12 of 30. All 30 manufacturers in China registered for Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Record

Regulatory record for Cardinal Health
Listed by Cardinal Health 200, LLC, United States
FDA product code GCX
Device type Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class Class 2
Regulation 21 CFR 880.6740
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2017-03-29
Record revised 2026-06-23 (version 10)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Supplied as a kit Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Storage environment temperature 15 to 30 °C
Packaging Case of 10, case of 12, case of 4, case of 50, case of 16, case of 20
Sizes Length 25 cm; catheter gauge 12 Fr
Distribution end date 2025-12-12

Catalogue Numbers

Catalogue numbers for Cardinal Health
Catalogue number Size Per pack Status
30-CE3CO In distribution
PH36TTTHB In distribution
30-CE11CO In distribution
K71 10 In distribution
SANOCUPHRA In distribution
30-CE2COAF In distribution
SBAOCDPGH4 In distribution
65652-158 In distribution
30-7361B In distribution
FG71-14228 350 In distribution
30-4206B In distribution
SANHDTSCH1 In distribution
PH36TTTH7 In distribution
30-CE6CO In distribution
PGMVTHNMG In distribution
30-3223D In distribution
30-0130G In distribution
SBA23PT275 In distribution
30-3223I In distribution
K62 In distribution
30-0130Q In distribution
FG65-4039 500 In distribution
30-1659D In distribution
PH36TTTH4 In distribution
30-7361J In distribution
30-0132H In distribution
30-7971B In distribution
888850103K In distribution
PGMVPANM2 In distribution
30-8179H In distribution
30-7361E In distribution
30-3223E In distribution
SBAOCDPGH7 In distribution
30-3447P In distribution
30-3319A In distribution
K60 In distribution
SAN53PTTC5 In distribution
30-3447H In distribution
SAN53PTTCB In distribution
30-7479G In distribution
SAN53PTT10 In distribution
30-8179C In distribution
30-8179D In distribution
30-4206A In distribution
SAN41PR211 In distribution
PH36TTT10 In distribution
30-4206C In distribution
30-0130T In distribution
FG65-4040L 500 In distribution
PH36TTTH8 In distribution
SAN31THNMF In distribution
30-0132B In distribution
30-0130P In distribution
K86 In distribution
SANOCTHSEA In distribution
30-5578 In distribution
30-8944A In distribution
SAN40RDABA In distribution
FG65-4038 500 In distribution
30-0145C In distribution
SAN15PPUMB In distribution
30-0130R In distribution
SBA23PT276 In distribution
PGMVTHNM8 In distribution
30-0130O In distribution
30-CE19SF In distribution
PH36TTTH5 In distribution
SANHDTSCHA In distribution
30-3447B In distribution
PH36TTTH3 In distribution
30-0145J In distribution
SAN53PTTC3 In distribution
SBAOCDPGH5 In distribution
SBAOCDPGHC In distribution
SBA23PT273 In distribution
30-3223G In distribution
SBAOCDPGHE In distribution
65651-208 60 In distribution
30-0132C In distribution
30-8920F In distribution
K770 50 In distribution
SAN15PPUMC In distribution
SANOCUPHRD In distribution
30-4206F In distribution
30-0132A In distribution
SAN40RDAB6 In distribution
PV36TTTHB In distribution
30-8179M In distribution
30-3447C In distribution
PH36TTTH2 In distribution
30-0145G In distribution
SAN40RDAB3 In distribution
SAN53PTTC1 In distribution
30-7479I In distribution
30-7077B In distribution
65652-000 In distribution
SAN31PANM6 In distribution
K86V In distribution
30-7361F In distribution
30-0145A In distribution
30-0130F In distribution
30-7361A In distribution
30-1659B In distribution
30-3223F In distribution
30-7971C In distribution
30-7971E In distribution
SAN31PANM7 In distribution
SAN40RDABB In distribution
SAN15PPUM3 In distribution
30-0145F In distribution
K61 In distribution
30-4572B In distribution
30A9334 In distribution
SBAOCDPGHA In distribution
30-CE8CA In distribution
FG71-14227 350 In distribution
30-2038B In distribution
SANOCUPHR1 In distribution
30-8179B In distribution
30-4572C In distribution
30-7361D In distribution
PGMVTHNM9 In distribution
30-8179N In distribution
30-3447K In distribution
FG71-24225 350 In distribution
30-CE2SFA In distribution
30-3447E In distribution
30-8179K In distribution
30-7361I In distribution
30-0130M In distribution
30-7479D In distribution
888850102K In distribution
30-7479E In distribution
PGMVPANME In distribution
30-0130N In distribution
K87V In distribution
30-0413B In distribution
K87 In distribution
PGMVTHNMH In distribution
30-7307A In distribution
SBAHDTSCH5 In distribution
FG65-4037 500 In distribution
888850400K Length 25 cm In distribution
SAN40RDAB5 In distribution
30-0145H In distribution
SAN53PTTC7 In distribution
30-8920B In distribution
KEX61V In distribution
30-0413A In distribution
FG71-24230 350 In distribution
SBA23PT27F In distribution
17-5841A In distribution
65652-589 In distribution
SANOCUPHRB In distribution
K72 10 In distribution
SBA23PT271 In distribution
30-CE11SF In distribution
30-CE8SADF In distribution
30-0130K In distribution
30-CE16SF In distribution
30-8179G In distribution
SAN53PTTCA In distribution
30-CE2SFAF In distribution
K73 10 In distribution
SAN53PTT12 In distribution
30-7971J In distribution
30-8920A In distribution
SAN53PTT13 In distribution
SBAOCDPGHD In distribution
SAN40RDAB8 In distribution
SAN15PPUMA In distribution
FG71-14230 350 In distribution
SAN31PANMF In distribution
30-7971H In distribution
30-8920C In distribution
30-1659A In distribution
30-3447A In distribution
30-CE1SF In distribution
FG65-4039L 500 In distribution
30-7971D In distribution
30-CE1CO In distribution
30-5324C In distribution
FG71-14225 350 In distribution
30-0130L In distribution
SANOCUPHR2 In distribution
SIDW1SCWBA In distribution
30-0132E In distribution
SAN53PTT11 In distribution
30-8920G In distribution
30-8920H In distribution
PGMVPANMD In distribution
30-0132D In distribution
30-7361K In distribution
30-3447G In distribution
SAN53PTTC4 In distribution
SBAOCDPGH1 In distribution
30-5324A In distribution
30-3447F In distribution
SAN31PANMH In distribution
30-3447Q In distribution
30-0132F In distribution
30-7361H In distribution
2-542ACE 30 In distribution
KEX61 In distribution
PH36TTTHA In distribution
65652-141 In distribution
30-4572D In distribution
30-0130H In distribution
PGMVTHN10 In distribution
SANOCUPHRC In distribution
30-CE18SF In distribution
30-0130E In distribution
30-7971F In distribution
PH36TTT12 In distribution
SAN40RDA10 In distribution
65652-588 In distribution
SAN53PTTC6 In distribution
SAN53PTTC2 In distribution
30-7479C In distribution
30-0130I In distribution
30-8179I In distribution
30-2038 In distribution
SID76CTMDA In distribution
30-7971I In distribution
30-0130V In distribution
30-0132G In distribution
17-5841B In distribution
30-8179F In distribution
SAN15PPUM2 In distribution
30-7479B In distribution
SAN40RDAB4 In distribution
30-9334B In distribution
FG65-4037L 500 In distribution
PH36TTTH1 In distribution
SANOCUPHR3 In distribution
29-6667A In distribution
30-7479A In distribution
30-CE15CO In distribution
30-0145I In distribution
SBAHDTSCHG In distribution
30-3223C In distribution
30-0130D In distribution
SBAOCDPGH6 In distribution
30-CE1SFCA In distribution
SAN40RDAB7 In distribution
30-3447D In distribution
888850200K In distribution
888850101K In distribution
30-4206G In distribution
30-3447M In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Vacutron Allied Medical LLC 764
Aesculap Aesculap AG 243
Single Use Professional Eakin Surgical Ltd 168
Medi-VAC Cardinal Health 200, LLC 158
MSI Precision Specialty Instruments MED Saver, Inc. 121
Du-O-Vac W.T. Farley, Inc. 91
Ambler Surgical Ambler Surgical, LLC 66
Apparatus, Suction, Operating-Room, Wall Vacuum Powered Biomet Microfixation 65
Wexler Surgical, Inc. Wexler Surgical, Inc. 44
OMT LLC OMT, LLC 39
Argyle Cardinal Health 38
Argyle Cardinal Health 200, LLC 34

Showing 12 of 257. All products under Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Recalls

5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2025-12-26 Class II Error in labeling The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may co 1,169,726 units
2023-12-21 Class II Process control The above-listed lots of Cardinal Health Medi-Vac CRD” Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister. 203244 units
2023-12-21 Class II Process control The above-listed lots of Cardinal Health Medi-Vac CRD” Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister. 3505730 units
2023-12-21 Class II Process control The above-listed lots of Cardinal Health Medi-Vac CRD” Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister. 74515
2018-03-28 Class II Process control products may be missing a one-way valve on the fluid patient port. 3600 units 2018-11-29

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