Identity
- Trade Name
- AMSure®Sterile Normal Saline for Wound Flush FDA UDI
- Generic Name
- Wound irrigation sterile saline FDA UDI
- Device Name
- 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 home care and should only be used by clinicians familiar with the treatment of possible complications. FDA UDI
- Model / Reference
- 1 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 home care and should only be used by clinicians familiar with the treatment of possible complications. FDA UDI
Identifiers
- Catalog Number
- AS398-1 FDA UDI
- Primary DI / UDI-DI
- 00704411010350 FDA UDI
- 510(k) Number
- K181423 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound irrigation sterile saline FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (1)
- FDA UDI b99e8ae0-2370-4c5d-92bf-2edec9da232f 35 fields · synced May 30, 2026