Identity
- Trade Name
- Flexicare EUDAMEDFDA UDIHygrovent Child Angled Bacterial Viral HMEF FDA UDI
- Generic Name
- Wearable adult urine collection bag, open-ended FDA UDIHeat/moisture exchanger/microbial medical gas filter FDA UDI
- Device Name
- Filters - Heat and Moisture Exchangers EUDAMEDLeg Bag 500ml Long Tube with Fabric Backing FDA UDI
- Model / Reference
- 301-510-000U EUDAMEDFDA UDI00-2502U FDA UDI
- Description
- Leg Bag 500ml Long Tube with Fabric Backing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788792154 EUDAMEDFDA UDI05055788766513 FDA UDI
- Basic UDI-DI
- B-05055788792154 EUDAMED
- FDA Product Code
- FAQ FDA UDICAH FDA UDI
- EMDN Code
- R040201 TRACHEOSTOMY HUMIDIFIERS EUDAMED
- GMDN Term
- Wearable adult urine collection bag, open-ended FDA UDIHeat/moisture exchanger/microbial medical gas filter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDIClass II FDA UDI
- Regulation Number
- 876.5250 FDA UDI868.5260 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDIFDA 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 UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wearable adult urine collection bag, open-ended
Flexicare by Flexicare Medical Limited — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- Urine Bag — Well Lead Medical Co., Ltd · Class II
- Leg Bag — C. R. Bard, Inc. · Class I
- Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) — UROCARE PRODUCTS, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Dover — Cardinal Health 200, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (3)
- FDA UDI dfce2a1f-4618-4e28-85c9-3a25bc3fe12c 33 fields · synced Sep 17, 2026
- FDA UDI a8a35aef-b555-41e7-a051-cb1cc3f80101 32 fields · synced May 30, 2026
- EUDAMED 2d8c2d90-f3e2-4553-ac65-e39bbb26c06f 61 fields · synced Sep 17, 2026