Identity
- Trade Name
- 088 x 125 cm Full Length Access System FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- 088 x 125 cm Full Length Access System; Contains Tenzing 8 Delivery Catheter (00853799007299) and 088 x 125 cm Full Length Catheter (00853799007077) FDA UDI
- Model / Reference
- Gen 1 FDA UDI
- Description
- 088 x 125 cm Full Length Access System; Contains Tenzing 8 Delivery Catheter (00853799007299) and 088 x 125 cm Full Length Catheter (00853799007077) FDA UDI
Identifiers
- Catalog Number
- REF 4004 FDA UDI
- Primary DI / UDI-DI
- 00853799007145 FDA UDI
- FDA Product Code
- QJP FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
088 x 125 cm Full Length Access System by Route 92 Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Route 92 Medical, Inc.
Sources (1)
- FDA UDI 1d93d93b-ac18-4f08-a1f5-aaee6350b433 36 fields · synced May 31, 2026