Arrow

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: ARROW FDA UDI
Generic Name: Pulmonary artery balloon catheter, electrical FDA UDI
Device Name: THERMODILUTION CATH KIT: 7.5 FR 5-L FDA UDI
Model / Reference: IPN917246 FDA UDI
Description: THERMODILUTION CATH KIT: 7.5 FR 5-L FDA UDI

Identifiers

Catalog Number: AH-05050 FDA UDI
Primary DI / UDI-DI: 10801902180923 FDA UDI
510(k) Number: K895268 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

Dimensions & Sizes

Size: Length — 110 Centimeter FDA UDI
Catheter Gauge — 7.5 French FDA UDI

Category: Pulmonary artery balloon catheter, electrical

Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Pulmonary artery balloon catheter, electrical.

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CRITICATH SP5107-13 TD CATHETER — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
CRITICATH™ SP5107H TD CATHETER — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
CRITICATH(TM) SP5107HS TD CATHETER — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
Thermodilution Catheter and Accessories — BIOPTIMAL INTERNATIONAL PTE. LTD. · Class II
SWAN-GANZ — Edwards Lifesciences LLC · Class II

Cleared under the same submission

K895268 also covers:

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

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI cdc3e068-2a0c-4eef-8c8d-0c39fa4c079d 38 fields · synced May 30, 2026