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AMSure® Sterile Normal Saline for Wound Flush
FDA UDIEUDAMEDClass U (US FDA UDI)
Ref AS398K
Identity
- Trade Name
- AMSure® Sterile Normal Saline EUDAMEDAMSure® Sterile Normal Saline for Wound Flush FDA UDI
- Generic Name
- Wound irrigation sterile saline FDA UDI
- Device Name
- Sterile Water, and Sterile Normal Saline for Wound Flush EUDAMEDAMSure® Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile normal saline for wound flush are intended to be used in clinical and should only be used by clinicians familiar with the treatment of possible complications. FDA UDI
- Model / Reference
- AS398K EUDAMED1 FDA UDI
- Description
- AMSure® Sterile Normal Saline for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile normal saline for wound flush are intended to be used in clinical and should only be used by clinicians familiar with the treatment of possible complications. FDA UDI
Identifiers
- Catalog Number
- AS398 FDA UDI
- Primary DI / UDI-DI
- 00704411018929 EUDAMED00704411007442 FDA UDI
- Basic UDI-DI
- B-00704411018929 EUDAMED
- 510(k) Number
- K181423 FDA UDI
- FDA Product Code
- FRO FDA UDI
- EMDN Code
- M04040101 SALINE DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Wound irrigation sterile saline FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU 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: Wound irrigation sterile saline
AMSure® Sterile Normal Saline for Wound Flush by Amsino International, Inc. — Class U — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
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 U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (2)
- FDA UDI 86664127-7cc5-432c-bf41-56dbc0ec7df8 35 fields · synced Aug 1, 2026
- EUDAMED fd367d92-3005-4969-9337-281b2ea1bbb5 61 fields · synced Aug 1, 2026