Transit

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name: TRANSIT FDA UDI
Generic Name: Vascular microcatheter FDA UDI
Device Name: TRANSIT Infusion Catheter Outer Diameter (Distal) 2.5F (0.85 mm) Usable Length 135 cm 2.8F (0.95 mm) .021 Inch (0.5 mm) 30cm Minimum Guiding Catheter I.D. .042 Inch (1.1 mm) (.038 Inch/.97 mm guidewire compatible). FDA UDI
Model / Reference: 600-330 FDA UDI
Description: TRANSIT Infusion Catheter Outer Diameter (Distal) 2.5F (0.85 mm) Usable Length 135 cm 2.8F (0.95 mm) .021 Inch (0.5 mm) 30cm Minimum Guiding Catheter I.D. .042 Inch (1.1 mm) (.038 Inch/.97 mm guidewire compatible). FDA UDI

Identifiers

Catalog Number: 600330 FDA UDI
Primary DI / UDI-DI: 10886704028246 FDA UDI
510(k) Number: K972518 FDA UDI
FDA Product Code: KRA FDA UDI
GMDN Term: Vascular microcatheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vascular microcatheter

Transit by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular microcatheter.

Velocity Delivery Microcatheter — PENUMBRA, INC. · Class II
Knight Microcatheter — ZIEN Medical Technologies, LLC · Class II
Merit Pursue™ — Merit Medical Systems, Inc. · Class I
Renegade™ HI-FLO™ Kit — Boston Scientific · Class II
Merit Maestro® — Merit Medical Systems, Inc. · Class II
Lantern Delivery Catheter — PENUMBRA, INC. · Class II
Direxion™ Fathom™-16 System — Boston Scientific · Class II
Direxion™ — Boston Scientific · Class II

Cleared under the same submission

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

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Manufacturer

Manufacturer: Medos International Sàrl

Sources (1)

FDA UDI b5967ff4-9f37-4ca4-a074-aea0d6b247da 37 fields · synced May 30, 2026