Identity
- Trade Name
- Hollister FDA UDI
- Generic Name
- Wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Vented Urinary Leg Bag Combination Pack FDA UDI
- Model / Reference
- 9645 FDA UDI
- Description
- Vented Urinary Leg Bag Combination Pack FDA UDI
Identifiers
- Catalog Number
- 9645 FDA UDI
- Primary DI / UDI-DI
- 00610075096459 FDA UDI
- FDA Product Code
- EYZ FDA UDI
- GMDN Term
- Wearable adult urine collection bag, open-ended FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 540 Milliliter FDA UDI
Category: Wearable adult urine collection bag, open-ended
Hollister by Hollister Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable adult urine collection bag, open-ended.
- SteriGear — Sterigear, LLC · Class II
- Urine Bag — Well Lead Medical Co., Ltd · Class II
- Urine Bag — Well Lead Medical Co., Ltd · Class II
- Flexicare — FLEXICARE MEDICAL LIMITED · Class I
- Urine Bag — Well Lead Medical Co., Ltd · Class II
- Flexicare — FLEXICARE MEDICAL LIMITED · Class I
- Leg Bag — C. R. Bard, Inc. · Class I
- Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) — UROCARE PRODUCTS, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hollister Incorporated
Sources (1)
- FDA UDI 534a9c31-3a44-43e3-9141-9fd6b6eeaf16 36 fields · synced Jun 9, 2026