AccessGUDID - DEVICE: ARROW (50801902130155)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN037697
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CDC-41541-MPK1A
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 50801902130155
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 30801902130151

Device Description: Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen Midline

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":	Yes
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?
64573	Peripheral intravenous catheterization kit, non-sensing	A collection of non-powered devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PND	Midline catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161313	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
Catheter Gauge: 4.5 French

Device Record Status

Public Device Record Key: 1fcb8be3-55ce-4691-81e8-4165e693514b
Public Version Date: April 18, 2025
Public Version Number: 6
DI Record Publish Date: March 21, 2019