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AMSure® PVC Intermittent Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AS861010Ref AS861616Ref AS860616Ref AS861610Ref AS861006Ref AS861618Ref AS860612Ref AS860610Ref AS861606Ref AS861008Ref AS861614
Identity
- Trade Name
- AMSure® PVC Intermittent Catheter EUDAMEDFDA UDIAMSure® ® PVC Intermittent Catheter EUDAMED
- Generic Name
- Intermittent urethral drainage catheter, non-antimicrobial, reusable FDA UDI
- Device Name
- Urethral Catheter EUDAMEDAMSure® PVC Intermittent Catheter Male 16" Length Coude Tip FDA UDIAMSure® PVC Intermittent Catheter Male 16" Length FDA UDIAMSure® PVC Intermittent Catheter Pediatric 10" Length FDA UDIAMSure® PVC Intermittent Catheter Female 6" Length FDA UDI
- Model / Reference
- AS861010 EUDAMEDAS861616 EUDAMEDAS860616 EUDAMEDAS861610 EUDAMEDAS861006 EUDAMEDAS861618 EUDAMEDAS860612 EUDAMEDAS860610 EUDAMEDAS861606 EUDAMEDAS861008 EUDAMEDAS861614 EUDAMED1 FDA UDI
- Description
- AMSure® PVC Intermittent Catheter Male 16" Length Coude Tip FDA UDIAMSure® PVC Intermittent Catheter Male 16" Length FDA UDIAMSure® PVC Intermittent Catheter Pediatric 10" Length FDA UDIAMSure® PVC Intermittent Catheter Female 6" Length FDA UDI
Identifiers
- Catalog Number
- AS861618C FDA UDIAS861614 FDA UDIAS861006 FDA UDIAS861618 FDA UDIAS861008 FDA UDIAS861616 FDA UDIAS860612 FDA UDIAS861010 FDA UDIAS860610 FDA UDIAS861610 FDA UDIAS861606 FDA UDIAS860616 FDA UDI
- Primary DI / UDI-DI
- 10704411003748 EUDAMEDFDA UDI10704411003670 EUDAMEDFDA UDI10704411003762 EUDAMEDFDA UDI10704411003687 EUDAMEDFDA UDI10704411003755 EUDAMEDFDA UDI10704411003632 EUDAMEDFDA UDI10704411003694 EUDAMEDFDA UDI10704411003625 EUDAMEDFDA UDI10704411003724 EUDAMEDFDA UDI10704411003700 EUDAMEDFDA UDI10704411003656 EUDAMEDFDA UDI10704411007234 FDA UDI
- Basic UDI-DI
- B-10704411003694 EUDAMEDB-10704411003755 EUDAMEDB-10704411003656 EUDAMEDB-10704411003724 EUDAMEDB-10704411003670 EUDAMEDB-10704411003762 EUDAMEDB-10704411003632 EUDAMEDB-10704411003625 EUDAMEDB-10704411003700 EUDAMEDB-10704411003687 EUDAMEDB-10704411003748 EUDAMED
- FDA Product Code
- EZD FDA UDI
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
- GMDN Term
- Intermittent urethral drainage catheter, non-antimicrobial, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intermittent urethral drainage catheter, non-antimicrobial, reusable
AMSure® PVC Intermittent Catheter by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Intermittent urethral drainage catheter, non-antimicrobial, reusable.
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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 (23)
- FDA UDI 2ec5196f-8df9-4262-8e29-7dc845f52500 34 fields · synced Oct 6, 2026
- FDA UDI a19a43b6-a5fa-484b-87f1-188b159d85f6 34 fields · synced May 29, 2026
- FDA UDI b41bda9d-865f-4c81-bfca-5a75b2846d94 34 fields · synced May 29, 2026
- FDA UDI 7d4b403e-839f-49bc-a690-fdad02cf0089 34 fields · synced May 30, 2026
- FDA UDI 7b7c5fb1-ba43-44a9-89bd-10ba63ee2f7a 34 fields · synced May 30, 2026
- FDA UDI 21d6ac11-41e1-416b-81e8-198af883df58 34 fields · synced May 30, 2026
- FDA UDI a9073156-d2a5-4dca-9099-03f5b9f46d46 34 fields · synced May 30, 2026
- FDA UDI ced29007-c004-41cc-8bd2-d6a034306328 34 fields · synced May 30, 2026
- FDA UDI cd57f6d1-9ced-4012-a8d4-764831988183 34 fields · synced May 30, 2026
- FDA UDI e735dd95-b594-4480-8272-7f8c1d5e4a7f 34 fields · synced May 30, 2026
- FDA UDI d93a5a5d-b77f-46d0-885e-3ff8cc1132b2 34 fields · synced May 30, 2026
- FDA UDI f39f5252-9321-405b-a83f-ed1e21fc9310 34 fields · synced May 30, 2026
- EUDAMED ee39515e-7b47-4afa-bbf2-4a120f67c3fe 61 fields · synced Jul 9, 2026
- EUDAMED 7340c497-83f4-4e88-b1c2-50a68dd271ec 61 fields · synced Jul 9, 2026
- EUDAMED d180e522-2d6d-452c-9026-708daa0416a6 61 fields · synced Jul 9, 2026
- EUDAMED 954bc9eb-2003-4926-b388-b30d33566b91 61 fields · synced Jul 11, 2026
- EUDAMED a2c57eac-8697-454d-83e1-f1e8e7099a3b 61 fields · synced Jul 12, 2026
- EUDAMED 6f779c61-b86b-4448-9cb3-f0eaee1d89c8 61 fields · synced Jul 17, 2026
- EUDAMED 3c530d05-1c71-4c16-8c2f-afa695128cab 61 fields · synced Jul 26, 2026
- EUDAMED f415de60-9778-415b-914f-0c65a32a7105 61 fields · synced Jul 30, 2026
- EUDAMED 53be76d1-838b-429c-8055-b245aedb139b 61 fields · synced Jul 31, 2026
- EUDAMED 578503a6-3159-4586-8b90-2335e66bd340 61 fields · synced Jul 31, 2026
- EUDAMED 44e60185-43c1-4d73-9562-539acb8d1bb3 61 fields · synced Aug 3, 2026