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Vsi

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
VSI FDA UDI
Generic Name
Full blood count IVD, calibrator FDA UDI
Device Name
7198V FDA UDI
Model / Reference
IPN916057 FDA UDI
Description
7198V FDA UDI

Identifiers

Catalog Number
7198V FDA UDI
Primary DI / UDI-DI
10841156106904 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Full blood count IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 40 Centimeter FDA UDI
Catheter Gauge — 4 French FDA UDI
Needle Gauge — 21 Gauge FDA UDI

Category: Full blood count IVD, calibrator

Vsi by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Full blood count IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 5eafa59d-6e46-4f4a-baa0-0a92e2af1e2e 36 fields · synced May 30, 2026