Mongoose

FDA UDI

Class II (US FDA UDI)

by Togo Medikit Co., Ltd.

Identity

Trade Name: Mongoose FDA UDI
Generic Name: Angiographic catheter, single-use FDA UDI
Model / Reference: A-3JB1-60/0044 FDA UDI

Identifiers

Primary DI / UDI-DI: 04543527229043 FDA UDI
510(k) Number: K113819 FDA UDI
FDA Product Code: DQO FDA UDI
GMDN Term: Angiographic catheter, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 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: Angiographic catheter, single-use

Mongoose by Togo Medikit Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Angiographic catheter, single-use.

INFINITI — Cordis US Corp. · Class II
Performa® — Merit Medical Systems, Inc. · Class II
Performa® — Merit Medical Systems, Inc. · Class II
Torcon NB — COOK INCORPORATED · Class II
Performa® — Merit Medical Systems, Inc. · Class II
ConcierGE Guiding Excellence™ — Merit Medical Systems, Inc. · Class II
INFINITI — Cordis US Corp. · Class II
CXI — COOK INCORPORATED · Class II

Cleared under the same submission

K113819 also covers:

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: Togo Medikit Co., Ltd.

Sources (1)

FDA UDI c090d9e2-3abf-4929-bdc7-62590af5c507 35 fields · synced May 31, 2026