AccessGUDID - DEVICE: Peregrine System™ Infusion Catheter (00862468000356)

GUDID

Device Identifier (DI) Information

Brand Name: Peregrine System™ Infusion Catheter
Version or Model: FG32112
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ABLATIVE SOLUTIONS, INC.

Primary DI Number: 00862468000356
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078293273 *Terms of Use

Device Description: Peregrine System™ Infusion Catheter (3-4 mm), 510k, US

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:	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?
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRA	Catheter, Continuous Flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231279	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 86 Centimeter
Device Size Text, specify: 3-4mm
Outer Diameter: 0.077 Inch

Device Record Status

Public Device Record Key: 7b2ea29b-209f-441a-ad50-d62cb5b5fd76
Public Version Date: March 06, 2024
Public Version Number: 1
DI Record Publish Date: February 27, 2024