AccessGUDID - DEVICE: ARROW (30801902219085)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN929366
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ASK-01218-HM
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 30801902219085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 10801902219081

Device Description: Arterial Catheterization Kit

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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
64575	Peripheral artery cannula	A short, thin tube intended for short-term (<= 30 days) percutaneous access to a peripheral artery for invasive blood pressure monitoring and arterial blood sampling; it may in addition be intended for peripheral intravenous (IV) or subcutaneous use for blood sampling or administration of fluid/medication. Also referred to as a peripheral arterial catheter, it is used with an external blood pressure transducer (not included) to enable pressure measurements; it does not include electronic sensors and is not intended for advancement into the vasculature. It may include devices dedicated to introduction/function (e.g., introducer needle, guidewire, adaptor). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171146	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 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec08e73c-a9ce-4839-b81d-326fa9c9a3eb
Public Version Date: June 09, 2025
Public Version Number: 2
DI Record Publish Date: April 26, 2024