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CT TRI-PAK Sterile Disposable Syringe

FDA UDI

Class II (US FDA UDI)

by Bayer Medical Care Inc.

Identity

Trade Name
CT TRI-PAK Sterile Disposable Syringe FDA UDI
Generic Name
Angiographic syringe FDA UDI
Device Name
Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (CT - 200ML ENV/VIST SYRINGE KIT W/QFT) (60728656) FDA UDI
Model / Reference
CTP-200-FLS FDA UDI
Description
Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (CT - 200ML ENV/VIST SYRINGE KIT W/QFT) (60728656) FDA UDI

Identifiers

Catalog Number
CTP-200-FLS FDA UDI
Primary DI / UDI-DI
00616258005430 FDA UDI
510(k) Number
K924116 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
Angiographic 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

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Angiographic syringe

CT TRI-PAK Sterile Disposable Syringe by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Angiographic syringe.

Cleared under the same submission

K924116 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bayer Medical Care Inc.

Sources (1)

  • FDA UDI e087900c-aa39-4724-b8c6-477fffb19ea1 36 fields · synced Jun 9, 2026