FDA UDI
In Commercial Distribution
🇺🇸 United States
AMSure® Sterile Normal Saline for Wound Flush
DI: 00704411007442
·
Model: 1
·
AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMSure® Sterile Normal Saline for Wound Flush
- Primary DI
- 00704411007442
- Version / Model
- 1
- Catalog Number
- AS398
- Company Name
- AMSINO INTERNATIONAL, INC.
- Labeler DUNS
- 825673239
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-30
- Public Version
- 2
- Public Version Date
- 2019-12-02
- Public Version Status
- Update
- Public Device Record Key
- 86664127-7cc5-432c-bf41-56dbc0ec7df8
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37298 | Wound irrigation sterile saline | A sterile solution of sodium chloride (NaCl), sometimes with additional compounds, intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and is typically provided in an appropriate container. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00704411007442 | GS1 | ||||
| Package | 40704411007440 | GS1 | case | 48 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181423 | 000 |