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FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Electrocardiographic lead switching adaptor FDA UDI
Device Name
Sheath Adapter with Cath-Gard(R) Catheter Contamination Shield for use with 4 - 7 Fr. Catheters FDA UDI
Model / Reference
IPN924153 FDA UDI
Description
Sheath Adapter with Cath-Gard(R) Catheter Contamination Shield for use with 4 - 7 Fr. Catheters FDA UDI

Identifiers

Catalog Number
SA-09847 FDA UDI
Primary DI / UDI-DI
10801902208535 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Electrocardiographic lead switching adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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: Electrocardiographic lead switching adaptor

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

Similar devices

Also classified as Electrocardiographic lead switching adaptor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 4ea01cb7-aacd-4da5-b0d0-6caf7b1678c7 35 fields · synced May 30, 2026