AccessGUDID - DEVICE: ARROW (10801902160673)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN915291
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AI-07035
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 10801902160673
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: 5 Fr. 80 cm Reverse Berman Angiographic Balloon Catheter

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYG	CATHETER, FLOW DIRECTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K892530	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at normal room temperature away from direct exposure to light. Prolonged exposure to fluorescent light, sunlight or heat will damage the balloon

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 5 French
Length: 80 Centimeter

Device Record Status

Public Device Record Key: 25368a9d-2d45-4980-aeed-deaaebd34f77
Public Version Date: January 18, 2021
Public Version Number: 3
DI Record Publish Date: December 21, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20801902160670	5	10801902160673		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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