AccessGUDID - DEVICE: ARROW (10801902179347)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN919008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IAH-09047
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 10801902179347
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Refillable Helium tanks (European standard, BAM Valve) 2500 psi 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?
46097	Medical air refillable cylinder	A container designed as a refillable cylinder used to hold compressed medical air [a mixture of approximately 21% oxygen (O2) and 78% nitrogen (N2) and other inert gases] under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with medical air when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote medical air content. The cylinder is typically made of steel and must be used together with a pressure regulator in order to release the air at the correct working pressure. Medical air is used for life support, therapeutic purposes and in anaesthesia.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: less than 52 Degrees Celsius
Special Storage Condition, Specify: Store between -15 Celsius and 40 Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a959a4c0-79e5-46dc-b39b-81dbdc68e2d0
Public Version Date: March 12, 2025
Public Version Number: 8
DI Record Publish Date: September 22, 2021