Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Intra-aortic balloon pump FDA UDI
- Device Name
- Disposable Helium Tank For use with IABP FDA UDI
- Model / Reference
- IPN919007 FDA UDI
- Description
- Disposable Helium Tank For use with IABP FDA UDI
Identifiers
- Catalog Number
- IAH-09045 FDA UDI
- Primary DI / UDI-DI
- 10801902179354 FDA UDI
- 510(k) Number
- K060309 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe 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
Cleared under the same submission
K060309 also covers:
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
- ARROW — TELEFLEX INCORPORATED
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
- Teleflex Incorporated
Sources (1)
- FDA UDI d09a15e3-7e0e-4018-94c3-a5c9635b3f72 37 fields · synced Jun 8, 2026