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Disposable High Pressure Injector Syringe

FDA UDI

Class II (US FDA UDI)

by Wuxi Yushou Medical Appliances Co., Ltd.

Identity

Trade Name
Disposable High Pressure Injector Syringe FDA UDI
Generic Name
Contrast medium injection system syringe FDA UDI
Device Name
1-100ml Syringe, 1-150cm One-way Connecting Tube, 1-J-type Tubular Medicine Aspirator FDA UDI
Model / Reference
300100B FDA UDI
Description
1-100ml Syringe, 1-150cm One-way Connecting Tube, 1-J-type Tubular Medicine Aspirator FDA UDI

Identifiers

Primary DI / UDI-DI
06971352280461 FDA UDI
510(k) Number
K152906 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
Contrast medium injection system syringe 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: Contrast medium injection system syringe

Disposable High Pressure Injector Syringe by Wuxi Yushou Medical Appliances Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Contrast medium injection system syringe.

Cleared under the same submission

K152906 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wuxi Yushou Medical Appliances Co., Ltd.

Sources (1)

  • FDA UDI 801754aa-5529-49b6-8826-e88758c914cc 34 fields · synced Jun 6, 2026