FDA UDI
In Commercial Distribution
🇺🇸 United States
ON-Q* Pain Relief System with SILVERSOAKER* Antimicrobial Catheter
DI: 00193494000103
·
Model: PS25006-A-N
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ON-Q* Pain Relief System with SILVERSOAKER* Antimicrobial Catheter
- Primary DI
- 00193494000103
- Version / Model
- PS25006-A-N
- Catalog Number
- PS25006-A-N
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-23
- Public Version
- 2
- Public Version Date
- 2023-12-18
- Public Version Status
- Update
- Public Device Record Key
- 27d8735d-fbad-4f9a-ac2f-9152d23b8e74
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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 |
|---|---|---|---|---|
| MEB | Pump, infusion, elastomeric | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47211 | Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein-L3 fraction (AFP-L3) in a clinical specimen, using a fluorescent immunoassay method. It is typically used to aid in the diagnosis of hepatocellular carcinoma (HCC). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10193494000100 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 00193494000103 | GS1 |
Customer Contacts
- Phone
- +1(844)428-2667
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063530 | 000 |