Identity
- Trade Name
- ambIT* PIB/PCA Pump V1.5 FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- PIB-PCA v1.5 Pump FDA UDI
- Model / Reference
- 220572 FDA UDI
- Description
- PIB-PCA v1.5 Pump FDA UDI
Identifiers
- Catalog Number
- 220572 FDA UDI
- Primary DI / UDI-DI
- 00193494001315 FDA UDI
- 510(k) Number
- K162165 FDA UDI
- FDA Product Code
- MEA FDA UDIFRN FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter 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: Peripheral vascular intervention infusion catheter
ambIT* PIB/PCA Pump V1.5 by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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*IL Pump — 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* 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 |
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Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI f1523477-61ac-49ee-83eb-4e2e61502d77 36 fields · synced Jun 9, 2026