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Vaxcel

FDA UDI

Class II (US FDA UDI)

by Navilyst Medical, Inc.

Identity

Trade Name
Vaxcel FDA UDI
Generic Name
Peripherally-inserted central venous catheter FDA UDI
Device Name
Vaxcel PICC with PASV Valve - 6F x 60cm Dual Lumen Polyurethane Catheter MST-30 Kit FDA UDI
Model / Reference
45477 FDA UDI
Description
Vaxcel PICC with PASV Valve - 6F x 60cm Dual Lumen Polyurethane Catheter MST-30 Kit FDA UDI

Identifiers

Primary DI / UDI-DI
M001454770 FDA UDI
FDA Product Code
LJS FDA UDI
GMDN Term
Peripherally-inserted central venous catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5970 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
Outer Diameter — 1.95 Millimeter FDA UDI
Catheter Gauge — 6 French FDA UDI
Needle Gauge — 21 Gauge FDA UDI
Length — 60 Centimeter FDA UDI

Vaxcel by Navilyst 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

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Manufacturer

Manufacturer
Navilyst Medical, Inc.

Sources (1)

  • FDA UDI 1c1c69da-7806-42d3-a035-0ce0536c8e30 36 fields · synced Jun 8, 2026