AccessGUDID - DEVICE: ARROW (30801902134609)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN035447
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CDA-45552-VPS2
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 30801902134609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 10801902134605

Device Description: Arrowg+ard Blue Advance(TM) PICC pre-loaded with Arrow(R) VPS Precision(TM) Stylet

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:	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?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153487	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: less than 25 Degrees Celsius
Special Storage Condition, Specify: Store below 25°C (77°F). Avoid excessive heat above 30°C (86°F).

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 5.5 French

Device Record Status

Public Device Record Key: 7bef157d-812b-4477-a095-c550b3f72b97
Public Version Date: March 20, 2024
Public Version Number: 7
DI Record Publish Date: March 06, 2019