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Disposable Urinary Drainage Bag

FDA UDI

Class II (US FDA UDI)

by Gcmedica Enterprise Ltd.(wuxi)

Identity

Trade Name
Disposable Urinary Drainage Bag FDA UDI
Generic Name
Non-wearable adult urine collection bag, closed-ended FDA UDI
Device Name
2000 mL Urinary Drainage Bag, Vented Anti-Reflux Chamber, 48" Drainage Tube, Handle, Sample Port, Cap FDA UDI
Model / Reference
JH01B01 FDA UDI
Description
2000 mL Urinary Drainage Bag, Vented Anti-Reflux Chamber, 48" Drainage Tube, Handle, Sample Port, Cap FDA UDI

Identifiers

Primary DI / UDI-DI
06974500612589 FDA UDI
FDA Product Code
KNX FDA UDI
GMDN Term
Non-wearable adult urine collection bag, closed-ended FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Non-wearable adult urine collection bag, closed-ended

Disposable Urinary Drainage Bag by Gcmedica Enterprise Ltd.(wuxi) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-wearable adult urine collection bag, closed-ended.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gcmedica Enterprise Ltd.(wuxi)

Sources (1)

  • FDA UDI 968217f3-e589-4abf-91ff-8bc1518a7476 33 fields · synced May 31, 2026