Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Intra-aortic balloon pump FDA UDI
- Device Name
- AC3(TM) Australian Power Cord (16 Ft/5M) For use with IABP FDA UDI
- Model / Reference
- IPN001074 FDA UDI
- Description
- AC3(TM) Australian Power Cord (16 Ft/5M) For use with IABP FDA UDI
Identifiers
- Catalog Number
- IAA-14695 FDA UDI
- Primary DI / UDI-DI
- 00801902089441 FDA UDI
- FDA Product Code
- DSP FDA UDI
- GMDN Term
- Intra-aortic balloon pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3535 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 4.5 Meter FDA UDI
Category: Intra-aortic balloon pump
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intra-aortic balloon pump.
- CS300 Intra-Aortic Balloon Pump, French, 220V — Datascope Corp. · Class II
- CS300 Accessory Kit, Japanese 110 V — Datascope Corp. · Class II
- CS300 Intra-Aortic Balloon Pump, French, 110V — Datascope Corp. · Class II
- CS300 Intra-Aortic Balloon Pump, Refurbished, PORTUGUESE, NON-UTS, DOM — Datascope Corp. · Class II
- CS300 Accessory Kit, Portuguese, 110 V — Datascope Corp. · Class II
- CARDIOSAVE HYBRID TYPE K PLUG — Datascope Corp. · Class II
- CS300 Intra-Aortic Balloon Pump, German, 220V — Datascope Corp. · Class II
- ASSY CRM SWEDISH — Datascope Corp. · Class II
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
- Teleflex Incorporated
Sources (1)
- FDA UDI 5a7ee02c-5ecc-4e59-97e5-81407b3dceb3 36 fields · synced May 31, 2026