Identity
- Trade Name
- ARROW FDA UDI
- Generic Name
- Intra-aortic balloon catheter FDA UDI
- Device Name
- Ultra 8(R) IAB FDA UDI
- Model / Reference
- IPN039789 FDA UDI
- Description
- Ultra 8(R) IAB FDA UDI
Identifiers
- Catalog Number
- IAB-05830-U FDA UDI
- Primary DI / UDI-DI
- 10801902145755 FDA UDI
- FDA Product Code
- DSP FDA UDI
- GMDN Term
- Intra-aortic balloon catheter 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intra-aortic balloon catheter
Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MEGA 7.5 Fr. 40cc IAB (China) — 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 |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 6dbe9579-a40c-4b0d-9fca-c8778f7e68e1 35 fields · synced May 30, 2026