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SpectraVue

FDA UDI

Class II (US FDA UDI)

by Shenzhen Boon Medical Supply Co., Ltd.

Identity

Trade Name
SpectraVue FDA UDI
Generic Name
Angiography kit FDA UDI
Device Name
1-21'' Transfer Set with Swabable Valve and Ball Check Valve Spike FDA UDI
Model / Reference
700207-2D FDA UDI
Description
1-21'' Transfer Set with Swabable Valve and Ball Check Valve Spike FDA UDI

Identifiers

Catalog Number
99-HT-SK501FC FDA UDI
Primary DI / UDI-DI
06938327901707 FDA UDI
510(k) Number
K241109 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
Angiography kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 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: Angiography kit

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

Similar devices

Also classified as Angiography kit.

Cleared under the same submission

K241109 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 f5774ed0-07c1-487a-887c-05ef1bdd2233 37 fields · synced Jun 8, 2026