Identity
- Trade Name
- Zoom Catheter FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- Zoom 045 144 cm RC FDA UDI
- Model / Reference
- ICRC045144 FDA UDI
- Description
- Zoom 045 144 cm RC FDA UDI
Identifiers
- Catalog Number
- ICRC045144 FDA UDI
- Primary DI / UDI-DI
- 00812212030498 FDA UDI
- FDA Product Code
- NRY FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.045 Inch FDA UDIOuter Diameter — 0.062 Inch FDA UDICatheter Length — 144 Centimeter FDA UDI
Category: Thrombectomy suction catheter
Zoom Catheter by Imperative Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K202182 also covers:
K210996 also covers:
K242672 also covers:
- TracStar LDP Large Distal Platform — IMPERATIVE CARE INC.
- TracStar LDP Large Distal Platform — IMPERATIVE CARE INC.
- Zoom 88 Large Distal Platform — IMPERATIVE CARE INC.
- Zoom 88 Large Distal Platform Support — IMPERATIVE CARE INC.
- Zoom Catheter — IMPERATIVE CARE INC.
- Zoom Catheter — IMPERATIVE CARE INC.
- Zoom Catheter — IMPERATIVE CARE 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Imperative Care Inc.
Sources (1)
- FDA UDI 3b289b6e-7443-4ef7-acd2-32e1d9cb37f5 38 fields · synced Jun 6, 2026