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AMSure® Urine Meter Drainage Bag
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AS327200Ref UB2000TVRef UB2000TTRef AS328Ref UB2000PP
Identity
- Trade Name
- AMSure® Urine Meter Drainage Bag EUDAMEDFDA UDIAMSure® Urine Drainage Bag EUDAMED
- Generic Name
- Urine flowmeter, single-use FDA UDI
- Device Name
- Urine Meter EUDAMEDUrine Bag EUDAMEDAMSure® Urine Meter Drainage Bag Contents: 400 cc Urine Meter with 2600 ml Drainage Bag Caution: Avoid freezing and excessive heat. FDA UDIAMSure® Urine Meter Drainage Bag CONTENTS: 200cc Blow Molded Urine Meter with 2000mL Drainage Bag FDA UDI
- Model / Reference
- AS327200 EUDAMEDUB2000TV EUDAMEDUB2000TT EUDAMEDAS328 EUDAMEDUB2000PP EUDAMED1 FDA UDI
- Description
- AMSure® Urine Meter Drainage Bag Contents: 400 cc Urine Meter with 2600 ml Drainage Bag Caution: Avoid freezing and excessive heat. FDA UDIAMSure® Urine Meter Drainage Bag CONTENTS: 200cc Blow Molded Urine Meter with 2000mL Drainage Bag FDA UDI
Identifiers
- Catalog Number
- AS328 FDA UDIAS327200 FDA UDI
- Primary DI / UDI-DI
- 10704411013075 EUDAMEDFDA UDI10704411005490 EUDAMEDFDA UDI10704411021056 EUDAMED10704411021049 EUDAMED10704411007517 EUDAMED
- Basic UDI-DI
- B-10704411005490 EUDAMEDB-10704411021056 EUDAMEDB-10704411021049 EUDAMEDB-10704411013075 EUDAMEDB-10704411007517 EUDAMED
- FDA Product Code
- FFG FDA UDI
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
- GMDN Term
- Urine flowmeter, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1800 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
Yes
EUDAMEDEUDAMED
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: Urine flowmeter, single-use
AMSure® Urine Meter 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 (7)
- FDA UDI 6b3588f3-0da0-4e04-a229-5ea91caf9964 34 fields · synced Jul 31, 2026
- FDA UDI 513a0535-9b43-41db-80aa-9c36754b8189 34 fields · synced May 30, 2026
- EUDAMED 3126ffe0-05cb-4adb-9547-0c57068b8485 61 fields · synced Jul 10, 2026
- EUDAMED dee3e210-47fc-4cb6-b008-672aec2a2e58 61 fields · synced Jul 18, 2026
- EUDAMED e1021df6-6c9d-4cd6-8782-39dc81df5b28 61 fields · synced Jul 19, 2026
- EUDAMED e7df6a7b-cc37-4b4d-adfc-a7c2a51d805d 61 fields · synced Jul 23, 2026
- EUDAMED 68d26824-0a09-4167-a382-005cf94b1575 61 fields · synced Jul 31, 2026