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ON-Q* Pain Relief System with SELECT-A-FLOW* Variable Rate Controller
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ON-Q* Pain Relief System with SELECT-A-FLOW* Variable Rate Controller FDA UDI
- Generic Name
- Elastomeric infusion pump kit FDA UDI
- Device Name
- ON-Q* Pump with Select-A-Flow* FDA UDI
- Model / Reference
- SAF01 FDA UDI
- Description
- ON-Q* Pump with Select-A-Flow* FDA UDI
Identifiers
- Catalog Number
- SAF01 FDA UDI
- Primary DI / UDI-DI
- 00193494136109 FDA UDI
- 510(k) Number
- K063530 FDA UDI
- FDA Product Code
- MEB FDA UDI
- GMDN Term
- Elastomeric infusion pump kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Elastomeric infusion pump kit
ON-Q* Pain Relief System with SELECT-A-FLOW* Variable Rate Controller by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Elastomeric infusion pump kit.
- LMA — TELEFLEX INCORPORATED · Class II
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- LMA — TELEFLEX INCORPORATED · Class II
- Catheter Set, 190mm Cut-to Size, 9" Introducer + FlowSplitter — Ambu A/S · Class II
- LMA — TELEFLEX INCORPORATED · Class II
- 6" introducerStand alone, complementary accessory (to be used with ACT — Ambu A/S · Class II
Cleared under the same submission
K063530 also covers:
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
- Halyard — Avanos Medical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI cfd8bea5-9b8a-4e34-b848-0ee9ed0b6898 36 fields · synced Jun 9, 2026