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Surfacer Inside-Out Access Catheter System

FDA UDI

Class II (US FDA UDI)

by Bluegrass Vascular Technologies, Inc.

Identity

Trade Name
Surfacer Inside-Out Access Catheter System FDA UDI
Generic Name
Central venous catheter inside-out introduction set FDA UDI
Model / Reference
600200/A FDA UDI

Identifiers

Catalog Number
600200/A FDA UDI
Primary DI / UDI-DI
00860003451601 FDA UDI
510(k) Number
DEN190038 FDA UDI
FDA Product Code
QJH FDA UDI
GMDN Term
Central venous catheter inside-out introduction set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1342 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

Yes

FDA UDI

Category: Central venous catheter inside-out introduction set

Surfacer Inside-Out Access Catheter System by Bluegrass Vascular Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Central venous catheter inside-out introduction set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bluegrass Vascular Technologies, Inc.

Sources (1)

  • FDA UDI a958442c-46f9-4ba8-986f-5db67fb84ce9 35 fields · synced May 30, 2026