AccessGUDID - DEVICE: Seraket Tourniquets (70818087010824)

GUDID

Device Identifier (DI) Information

Brand Name: Seraket Tourniquets
Version or Model: 22712000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22712000
Company Name: PROPPER MANUFACTURING COMPANY, INC.

Primary DI Number: 70818087010824
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 120
Labeler D-U-N-S® Number*: 001483130 *Terms of Use

Device Description: Seraket Tourniquet - Case of 120

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):	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?
35844	Limb tourniquet, manual, reusable	A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It will typically have a fastening mechanism (e.g., Velcro or a self-locking buckle) that allows adjustments to the degree of tightness. This is a reusable device which may be intended for single- or multi-patient use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GAX	Tourniquet, Nonpneumatic

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: 5a5d38eb-168f-4997-aaca-e30b1ea6626f
Public Version Date: June 26, 2023
Public Version Number: 1
DI Record Publish Date: June 16, 2023