AccessGUDID - DEVICE: Primi™ Support Catheter (M781P14120150HF1)

GUDID

Device Identifier (DI) Information

Brand Name: Primi™ Support Catheter
Version or Model: P14-120-150HF
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thermopeutix, Inc.

Primary DI Number: M781P14120150HF1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 138648154 *Terms of Use

Device Description: The Primi™ Support Catheter is a single lumen catheter with an integrated spine wire and guidewire lumen designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to the distal vasculature. The Primi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of the catheter.

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:	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
DQY	Catheter, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130850	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
Handling Environment Temperature: between -29 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Sheath Compatibility: 6 Fr
Device Size Text, specify: Shaft Length: 150 cm
Device Size Text, specify: Tracking Length: 120 mm
Device Size Text, specify: Guide Wire Compatibility: 0.014”

Device Record Status

Public Device Record Key: b6edc156-b844-416a-89bc-1dd2b99ce4c8
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: September 19, 2016