AccessGUDID - DEVICE: Prodigy™ Catheter (00850032079068)

GUDID

Device Identifier (DI) Information

Brand Name: Prodigy™ Catheter
Version or Model: PRODIGY8F
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PRODIGY8F
Company Name: IMPERATIVE CARE, INC.

Primary DI Number: 00850032079068
Issuing Agency: GS1
Commercial Distribution End Date: August 07, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080816678 *Terms of Use

Device Description: 8F Prodigy™ Catheter Length: 90 cm Inner Diameter: 0.088 in Outer Diameter: 0.110 in (2.80 mm)

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?
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QEW	Peripheral Mechanical Thrombectomy With Aspiration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K214114	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: Store in a cool, dry place

Clinically Relevant Size

[?]

Size Type Text
Catheter Length: 90 Centimeter
Catheter Inner Diameter: 0.088 Inch
Outer Diameter: 0.110 Inch

Device Record Status

Public Device Record Key: d17720a5-0d76-4ce1-a2f3-cbd22b245f1d
Public Version Date: December 15, 2023
Public Version Number: 5
DI Record Publish Date: August 10, 2022