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
MEB Pump, infusion, elastomeric

GMDN Terms

Code Name
47211 Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay

Identifiers

Type ID
Package 10193494000100
Primary 00193494000103

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K063530 000