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Medical Imaging Solutions International

FDA UDI

Class II (US FDA UDI)

by Shenzhen Boon Medical Supply Co., Ltd.

Identity

Trade Name
Medical Imaging Solutions International FDA UDI
Generic Name
Angiographic catheter, single-use FDA UDI
Device Name
J tube FDA UDI
Model / Reference
700103 FDA UDI
Description
J tube FDA UDI

Identifiers

Catalog Number
700103 FDA UDI
Primary DI / UDI-DI
06938327900268 FDA UDI
510(k) Number
K151960 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
Angiographic catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 FDA UDI
Commercial Distribution
Not 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

Medical Imaging Solutions International by Shenzhen Boon Medical Supply Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151960 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Boon Medical Supply Co., Ltd.

Sources (1)

  • FDA UDI d483dbfe-670a-4b31-8194-fa0f8946c388 37 fields · synced Jun 1, 2026