FDA UDI
In Commercial Distribution
🇺🇸 United States
ON-Q* Pain Relief System
DI: 00193494450823
·
Model: 45082
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ON-Q* Pain Relief System
- Primary DI
- 00193494450823
- Version / Model
- 45082
- Catalog Number
- PS6508-N
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-07
- Public Version
- 3
- Public Version Date
- 2023-06-23
- Public Version Status
- Update
- Public Device Record Key
- 41eaa4d4-3df1-4fec-a4ab-5031b27be9e1
Device Description
ON-Q* Fixed Flow Pump Kits With ON-Q* Soaker* Catheter
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 |
|---|---|---|---|---|
| MEB | Pump, infusion, elastomeric | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47206 | Cardiac pulse generator software | An application or operating data program (i.e., primarily operating system software that may include some application program functionality) designed for use in or with an implantable cardioverter-defibrillator (ICD) and an implantable cardiac pacemaker so that the defibrillator and pacemaker function according to their intended purpose. This software program may be permanently installed or exchanged as an upgrade. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10193494450820 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 00193494450823 | GS1 |
Customer Contacts
- Phone
- +1(844)428-2667
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063530 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 400 | Milliliter | |
| Device Size Text, specify | Fill Volume (ml) |