AccessGUDID - DEVICE: ARROW (00801902042422)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN000264
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IAH-09045
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 00801902042422
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: AC3(TM) Australian Power Cord (16 Ft/5M) For use with IABP

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
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?
36340	Intra-aortic balloon pump	An electrically-powered device intended to inflate/deflate the balloon of an intra-aortic balloon catheter (not included) to assist cardiac function. The device monitors the patient’s electrocardiogram (ECG) and blood pressure to inflate/deflate the balloon in synchrony with the cardiac cycle, so that the balloon inflates after a cardiac contraction to increase perfusion of the coronary arteries and deflates before the next contraction to avoid obstructing aortic outflow. The device typically includes a main unit which incorporates a helium cylinder for balloon inflation/deflation, a screen, and controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSP	System, balloon, intra-aortic and control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060309	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 18 and 25 Degrees Celsius
Handling Environment Temperature: less than 52 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7084b4ff-9f21-4092-818d-f5ecf1d3a6c0
Public Version Date: February 07, 2025
Public Version Number: 20
DI Record Publish Date: October 16, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30801902042423	4	00801902042422		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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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