FDA UDI
In Commercial Distribution
🇺🇸 United States
ON-Q* Pain Relief System
DI: 00193494136291
·
Model: 13629
·
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
- 00193494136291
- Version / Model
- 13629
- Catalog Number
- PS6504-A
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-08
- Public Version
- 2
- Public Version Date
- 2023-06-23
- Public Version Status
- Update
- Public Device Record Key
- cd36290b-9b02-4f98-a1a8-de3fc8fbf8c7
Device Description
ON-Q* Fixed Flow Pump Kits With ON-Q* SilverSoaker* Catheter
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 47190 | Elastomeric infusion pump kit | A collection of sterile devices designed to enable a healthcare provider or patient to perform infusion therapy using an elastomeric infusion pump. The kit typically consists of the infusion pump and other devices such as a catheter, tunneller, needle, sheath, syringe, dressings, adhesive strips, and a filling device for the infusion pump. This device is typically used for the infusion of fluids, antibiotics, chemotherapeutic agents, or pain management medications in the healthcare facility or the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10193494136298 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 00193494136291 | 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 | 270 | Milliliter | |
| Device Size Text, specify | Balloon Fill Volume (ml) |