AccessGUDID - DEVICE: ARROW (10801902126877)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN001318
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ASK-42703-SJMT
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 10801902126877
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Arrowg+ard Blue Plus(R) Three-Lumen CVC Kit / Arrowg+ard Blue(R) PSI Kit for use with 7 Fr. Catheters

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?
61594	Central venous catheterization kit, short-term	A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993691	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
Special Storage Condition, Specify: Excursions permitted to 15 – 30C (59 – 86F). Protect from freezing.
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 7 French

Device Record Status

Public Device Record Key: b74d4b9f-1632-4c70-835a-67a26fdeffda
Public Version Date: March 01, 2024
Public Version Number: 14
DI Record Publish Date: September 16, 2016