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AMSure® Urinary Leg Bag
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref AS308NRef AS307NRef AS309NRef AS309FRef AS308T
Identity
- Trade Name
- AMSure® Urinary Leg Bag EUDAMEDFDA UDI
- Generic Name
- Wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Urine Bag EUDAMEDAMSure® Urinary Leg Bag Medium - 600 mL, Push-Pull Valve CONTENTS: One 600 mL Urinary Leg Bag equipped with Two Flexible Latex Free Straps, Anti- Reflux Valve, Push-Pull Valve, protective cap FDA UDIAMSure® Urinary Leg Bag Large - 900 mL, Push-Pull Valve CONTENTS: One 900 mL Urinary Leg Bag equipped with Two Flexible Latex Free Straps, Anti- Reflux Valve, Push-Pull Valve, protective cap FDA UDIAMSure® Urinary Leg Bag Medium - 600 mL CONTENTS: One 600 mL Urinary Leg Bag equipped with: T-valve drainage outlet, Anti- Reflux Valve, Two Latex-free Straps FDA UDIAMSure® Urinary Leg Bag Large - 900 mL, Flip Valve CONTENTS: One each 900 mL leg bag equipped with: Flip valve drainage outlet Anti-reflux valve Two latex-free straps FDA UDIAMSure® Urinary Leg Bag Medium - 600 mL, Twist Valve CONTENTS: One 600 mL Urinary Leg Bag equipped with Two Flexible Straps, Anti-reflux Valve, Twist Valve, protective cap FDA UDI
- Model / Reference
- AS308N EUDAMEDAS307N EUDAMEDAS309N EUDAMEDAS309F EUDAMEDAS308T EUDAMED1 FDA UDI
- Description
- AMSure® Urinary Leg Bag Medium - 600 mL, Push-Pull Valve CONTENTS: One 600 mL Urinary Leg Bag equipped with Two Flexible Latex Free Straps, Anti- Reflux Valve, Push-Pull Valve, protective cap FDA UDIAMSure® Urinary Leg Bag Large - 900 mL, Push-Pull Valve CONTENTS: One 900 mL Urinary Leg Bag equipped with Two Flexible Latex Free Straps, Anti- Reflux Valve, Push-Pull Valve, protective cap FDA UDIAMSure® Urinary Leg Bag Medium - 600 mL CONTENTS: One 600 mL Urinary Leg Bag equipped with: T-valve drainage outlet, Anti- Reflux Valve, Two Latex-free Straps FDA UDIAMSure® Urinary Leg Bag Large - 900 mL, Flip Valve CONTENTS: One each 900 mL leg bag equipped with: Flip valve drainage outlet Anti-reflux valve Two latex-free straps FDA UDIAMSure® Urinary Leg Bag Medium - 600 mL, Twist Valve CONTENTS: One 600 mL Urinary Leg Bag equipped with Two Flexible Straps, Anti-reflux Valve, Twist Valve, protective cap FDA UDI
Identifiers
- Catalog Number
- AS306N FDA UDIAS307N FDA UDIAS308T FDA UDIAS309F FDA UDIAS308N FDA UDI
- Primary DI / UDI-DI
- 10704411008248 EUDAMEDFDA UDI10704411008279 EUDAMEDFDA UDI10704411008286 EUDAMEDFDA UDI10704411008262 EUDAMEDFDA UDI10704411008293 EUDAMED10704411008231 FDA UDI
- Basic UDI-DI
- B-10704411008262 EUDAMEDB-10704411008248 EUDAMEDB-10704411008293 EUDAMEDB-10704411008286 EUDAMEDB-10704411008279 EUDAMED
- FDA Product Code
- FAQ FDA UDI
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
- GMDN Term
- Wearable adult urine collection bag, open-ended FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wearable adult urine collection bag, open-ended
AMSure® Urinary Leg Bag by Amsino International, Inc. — 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
- 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 (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
- Amsino International, Inc.
Sources (10)
- FDA UDI 106eb9e2-dd1e-4f82-bb15-9037e1e9b386 34 fields · synced Jul 26, 2026
- FDA UDI 88fafa0f-5589-47ca-8d5a-22609af48d7f 34 fields · synced May 25, 2026
- FDA UDI 3b5d2f37-be59-4146-a0ec-898643eb5bf1 34 fields · synced May 30, 2026
- FDA UDI fb596c81-c7bf-4b55-8189-cdc17620c602 34 fields · synced May 30, 2026
- FDA UDI 2f4b60f8-5586-4245-b5c6-546192be6cdb 34 fields · synced May 30, 2026
- EUDAMED 84446d81-1ce9-4399-8e1d-c73079dada27 61 fields · synced Jul 10, 2026
- EUDAMED c0952317-1d3c-4a4c-b4cf-09f85ff0b87f 61 fields · synced Jul 12, 2026
- EUDAMED f289bc89-d0fd-437d-af32-c6f6f6f38417 61 fields · synced Jul 16, 2026
- EUDAMED 4442c157-84a7-4747-91e3-b203400f1209 61 fields · synced Jul 25, 2026
- EUDAMED feefa42f-22f5-4e08-abc1-5562f92fdd3d 61 fields · synced Jul 26, 2026