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Angiographic 5fr 80cm C-tip

FDA UDI

Class II (US FDA UDI)

by Alpha Medical Instruments Llc

Identity

Trade Name
Angiographic 5fr 80cm C-tip FDA UDI
Generic Name
Pulmonary artery balloon catheter, non-electrical FDA UDI
Device Name
Angiographic Balloon Catheter FDA UDI
Model / Reference
252-80P FDA UDI
Description
Angiographic Balloon Catheter FDA UDI

Identifiers

Catalog Number
252-80P FDA UDI
Primary DI / UDI-DI
M82225280P2 FDA UDI
510(k) Number
K920870 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Pulmonary artery balloon catheter, non-electrical 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

No

FDA UDI

Contains Latex

Yes

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: Pulmonary artery balloon catheter, non-electrical

Angiographic 5fr 80cm C-tip by Alpha Medical Instruments Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary artery balloon catheter, non-electrical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alpha Medical Instruments Llc

Sources (1)

  • FDA UDI cece1314-eef8-4507-9be1-01287368095a 37 fields · synced May 30, 2026