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AMSure® Urinary Drainage Bag
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AS332Ref AS326Ref AS312Ref AS322Ref AS32200Ref AS32600
Identity
- Trade Name
- AMSure® Urinary Drainage Bag EUDAMEDFDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Urine Bag EUDAMEDAMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: Anti-reflux flutter valve, Universal hanger, T-valve drainage outlet, Air vent, Sampling adapter, Protective cap FDA UDIAMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: Metal clamp and splash guard, Air-vent, Universal hanger, Sampling adapter, Anti-reflux drip chamber, Protective cap FDA UDIAMSure® Urinary Drainage Bag Pear Shape CONTENTS: One 2000mL drainage bag equipped with: Large anti-reflux chamber, Universal double-hook hanger, Bed sheet clamp, T-valve drainage outlet, Air vent, Sampling adapter, Protective cap FDA UDIAMSure® Urinary Drainage Bag Low Profile with Luer Slip and Luer Lock Sampling Port CONTENTS: One each 2000mL drainage bag equipped with: Large anti-reflux chamber, Universal hook hanger, Bed sheet clamp, T-valve drainage outlet, Luer Slip and Luer Lock Sampling Port FDA UDIAMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: T-valve drainage outlet, Air vent, Universal hanger, Sampling adapter, Anti-reflux drip chamber, Protective cap FDA UDIAMSure® Urinary Drainage Bag Pear Shape CONTENTS: One each 2000mL drainage bag equipped with: Large anti-reflux chamber, Universal hook hanger, Bed sheet clamp, T-valve drainage outlet, AMSecure® needleless sampling adapter FDA UDI
- Model / Reference
- AS332 EUDAMEDAS326 EUDAMEDAS312 EUDAMEDAS322 EUDAMEDAS32200 EUDAMEDAS32600 EUDAMED1 FDA UDI
- Description
- AMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: Anti-reflux flutter valve, Universal hanger, T-valve drainage outlet, Air vent, Sampling adapter, Protective cap FDA UDIAMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: Metal clamp and splash guard, Air-vent, Universal hanger, Sampling adapter, Anti-reflux drip chamber, Protective cap FDA UDIAMSure® Urinary Drainage Bag Pear Shape CONTENTS: One 2000mL drainage bag equipped with: Large anti-reflux chamber, Universal double-hook hanger, Bed sheet clamp, T-valve drainage outlet, Air vent, Sampling adapter, Protective cap FDA UDIAMSure® Urinary Drainage Bag Low Profile with Luer Slip and Luer Lock Sampling Port CONTENTS: One each 2000mL drainage bag equipped with: Large anti-reflux chamber, Universal hook hanger, Bed sheet clamp, T-valve drainage outlet, Luer Slip and Luer Lock Sampling Port FDA UDIAMSure® Urinary Drainage Bag CONTENTS: One 2000mL drainage bag equipped with: T-valve drainage outlet, Air vent, Universal hanger, Sampling adapter, Anti-reflux drip chamber, Protective cap FDA UDIAMSure® Urinary Drainage Bag Pear Shape CONTENTS: One each 2000mL drainage bag equipped with: Large anti-reflux chamber, Universal hook hanger, Bed sheet clamp, T-valve drainage outlet, AMSecure® needleless sampling adapter FDA UDI
Identifiers
- Catalog Number
- AS332 FDA UDIAS326 FDA UDIAS322 FDA UDIAS32600 FDA UDIAS312 FDA UDIAS32200 FDA UDI
- Primary DI / UDI-DI
- 10704411004134 EUDAMEDFDA UDI10704411004127 EUDAMEDFDA UDI10704411004110 EUDAMEDFDA UDI10704411003113 EUDAMEDFDA UDI10704411004103 EUDAMEDFDA UDI10704411003106 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411004134 EUDAMEDB-10704411004127 EUDAMEDB-10704411004103 EUDAMEDB-10704411004110 EUDAMEDB-10704411003106 EUDAMEDB-10704411003113 EUDAMED
- FDA Product Code
- KNX FDA UDI
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
- GMDN Term
- Non-wearable adult urine collection bag, open-ended FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 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: Non-wearable adult urine collection bag, open-ended
AMSure® Urinary Drainage Bag by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (12)
- FDA UDI 310482ed-d904-4eac-9ca6-3cfd4957f7bc 34 fields · synced Sep 18, 2026
- FDA UDI de86eea5-8fee-4fbf-9126-ccd558b94ded 34 fields · synced May 30, 2026
- FDA UDI df22d02d-4fe7-45d0-925e-a778b667d69c 34 fields · synced May 30, 2026
- FDA UDI 87957fa6-9e65-4720-9f33-0c42cb66fef3 34 fields · synced May 30, 2026
- FDA UDI 2c17e581-ae4c-41cd-8337-f626ada8a234 34 fields · synced May 30, 2026
- FDA UDI ad10ee79-fd7e-48ea-9959-157744fddb9d 34 fields · synced May 30, 2026
- EUDAMED eb0dfa67-58ce-4b4b-a004-6610ad089890 61 fields · synced Jul 9, 2026
- EUDAMED 199d6fd5-a45f-4a4e-bda1-fbd928d84d9f 61 fields · synced Jul 10, 2026
- EUDAMED e514bbc7-6f24-4f54-b758-4f8d7b8dbe9d 61 fields · synced Jul 11, 2026
- EUDAMED 92b93a3e-ee73-4516-afb1-642011953285 61 fields · synced Jul 12, 2026
- EUDAMED 068a04c0-a172-464e-9f0e-b0db6cfa4772 61 fields · synced Jul 29, 2026
- EUDAMED 459faa31-f9dc-4336-9171-120b04b3e5dd 61 fields · synced Sep 18, 2026