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ZOOM™ 88 Large Distal Platform

FDA UDI

Class II (US FDA UDI)

by Imperative Care Inc.

Identity

Trade Name
ZOOM™ 88 Large Distal Platform FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
ZOOM™ 88 6F 088 LDP, 110 cm FDA UDI
Model / Reference
ICFC088110 FDA UDI
Description
ZOOM™ 88 6F 088 LDP, 110 cm FDA UDI

Identifiers

Catalog Number
ICFC088110 FDA UDI
Primary DI / UDI-DI
00812212030153 FDA UDI
510(k) Number
K180169 FDA UDI
FDA Product Code
DQY 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

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 — 0.088 Inch FDA UDI
Outer Diameter — 0.108 Inch FDA UDI
Catheter Length — 110 Centimeter FDA UDI

ZOOM™ 88 Large Distal Platform by Imperative Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K180169 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Imperative Care Inc.

Sources (1)

  • FDA UDI 77985712-a8a6-44ba-8031-ced8cd10348c 39 fields · synced Jun 1, 2026