AccessGUDID - DEVICE: Calibration Hose Set for PTS BFR, plastic Female (M995922006103)

GUDID

Device Identifier (DI) Information

Brand Name: Calibration Hose Set for PTS BFR, plastic Female
Version or Model: 9-2200-610
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Delfi Medical Innovations Inc

Primary DI Number: M995922006103
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251078945 *Terms of Use

Device Description: Calibration Hose set for the use with PTS BFR Tourniquet System

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:	No
Prescription Use (Rx):	No
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?
14074	Surgical pneumatic tourniquet system	A device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCY	Tourniquet, Pneumatic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 3e8d31e2-9a83-493d-a35d-140c6b66891c
Public Version Date: June 02, 2023
Public Version Number: 1
DI Record Publish Date: May 25, 2023