AccessGUDID - DEVICE: INSPIRA ART100 (07290117830062)

GUDID

Device Identifier (DI) Information

Brand Name: INSPIRA ART100
Version or Model: INSPIRA ART100 Emergency Manual Pump Drive
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INS-010301
Company Name: INSPIRA TECHNOLOGIES OXY B.H.N LTD

Primary DI Number: 07290117830062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531834876 *Terms of Use

Device Description: No description.

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:	No
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?
36858	Centrifugal circulatory assist pump, manual	A centrifugal pump that is manually hand cranked (rotated) by the perfusionist or operator present in order to substitute for the electrically-operated pump during a power outage. It is a specially constructed pump used to provide circulatory assistance (support of the blood circulation when the heart fails) to the patient due to his/her dependence upon artificial assistance in order to maintain the body's heart function.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWA	Control, Pump Speed, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232788	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 137bb6b5-dc1f-4f8a-bb41-0e2722bf1cb2
Public Version Date: November 18, 2024
Public Version Number: 1
DI Record Publish Date: November 10, 2024