Thermodilution 7FR 110cm Modified J-tip

FDA UDI

Class II (US FDA UDI)

by Alpha Medical Instruments Llc

Identity

Trade Name: Thermodilution 7FR 110cm Modified J-tip FDA UDI
Generic Name: Pulmonary artery balloon catheter, electrical FDA UDI
Device Name: Thermodilution Catheter FDA UDI
Model / Reference: 474-110P FDA UDI
Description: Thermodilution Catheter FDA UDI

Identifiers

Catalog Number: 474-110P FDA UDI
Primary DI / UDI-DI: M822474110P0 FDA UDI
510(k) Number: K920869 FDA UDI
FDA Product Code: DYG FDA UDI
GMDN Term: Pulmonary artery balloon catheter, electrical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1240 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulmonary artery balloon catheter, electrical

Thermodilution 7FR 110cm Modified J-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, electrical.

ARROW — TELEFLEX INCORPORATED · Class II
CRITICATH(TM) SP5107 TD CATHETER — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
SWAN-GANZ VIP — Edwards Lifesciences LLC · Class II
SWAN-GANZ CONTROLCATH TRUE SIZE — Edwards Lifesciences LLC · Class II
CRITICATH SP5107-13 TD CATHETER — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
ARROW — TELEFLEX INCORPORATED · Class II
ARROW — TELEFLEX INCORPORATED · Class II
ARROW — TELEFLEX INCORPORATED · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Alpha Medical Instruments Llc

Sources (1)

FDA UDI 717caa6b-8e83-48c0-9e36-86ac55af8090 37 fields · synced May 30, 2026