AccessGUDID - DEVICE: REVIVE (10886704074779)

GUDID

Device Identifier (DI) Information

Brand Name: REVIVE
Version or Model: PV21452200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PV21452200
Company Name: Medos International Sàrl

Primary DI Number: 10886704074779
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: REVIVE PV peripheral vascular thrombectomy device 4.5mm x 22mm 6 mm 205 cm 0.014 Inch Peripheral Vascular Thrombectomy Device Recommended Microcatheter .027 Inch Contents: 1 Thrombectomy Device, 1 Introducer

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
DXE	CATHETER, EMBOLECTOMY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132281	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: between 0 and 60 Degrees Celsius
Handling Environment Temperature: between 32 and 140 Degrees Fahrenheit
Storage Environment Temperature: between 32 and 140 Degrees Fahrenheit
Handling Environment Temperature: between 0 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3d4842f0-cf1a-4a04-a5ce-1989cc75a503
Public Version Date: November 29, 2023
Public Version Number: 6
DI Record Publish Date: June 30, 2016