Identity
- Trade Name
- ambIT* PIB*IL Pump FDA UDI
- Generic Name
- Ambulatory non-insulin infusion pump, electronic FDA UDI
- Device Name
- PIB*IL Pump FDA UDI
- Model / Reference
- 220527 FDA UDI
- Description
- PIB*IL Pump FDA UDI
Identifiers
- Catalog Number
- 220527 FDA UDI
- Primary DI / UDI-DI
- 00193494000769 FDA UDI
- 510(k) Number
- K162165 FDA UDI
- FDA Product Code
- FRN FDA UDIMEA FDA UDI
- GMDN Term
- Ambulatory non-insulin infusion pump, electronic 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Category: Ambulatory non-insulin infusion pump, electronic
ambIT* PIB*IL Pump by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ambulatory non-insulin infusion pump, electronic.
- Remunity — United Therapeutics Corporation · Class II
- RemunityPRO — United Therapeutics Corporation · Class II
- ambIT — Summit Medical Products, Inc. · Class II
- Crono — CANE' SPA · Class II
- Nimbus II PainPRO — INFUTRONIX LLC · Class II
- WalkMed® — WalkMed Technologies, LLC · Class II
- ambIT — Summit Medical Products, Inc. · Class II
- On-body Infusor for Furoscix® — SCPHARMACEUTICALS INC. · Class II
Cleared under the same submission
K162165 also covers:
- ambIT* Cassette - Filter, Male Neuraxial Connector — Avanos Medical, Inc.
- ambIT* DISPOSABLE PLUS — Avanos Medical, Inc.
- ambIT* KIDS PIB Pump-Blue — Avanos Medical, Inc.
- ambIT* PIB IL v 1.5 — Avanos Medical, Inc.
- ambIT* PIB-PCA Pump — Avanos Medical, Inc.
- ambIT* PIB-PCA v1.5 System w/Male Filter Cass — Avanos Medical, Inc.
- ambIT* PIB-PCA v1.5 System w/Spike Filter Cass — Avanos Medical, Inc.
- ambIT* PIB/PCA Pump V1.5 — Avanos Medical, Inc.
- ambIT* Remote Bolus Switch — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI a4e0107c-d15b-4b6e-b7b6-a565b466cf43 36 fields · synced Jun 9, 2026