AccessGUDID - DEVICE: Pressure Cuff Size 1.6 (07290016880519)

GUDID

Device Identifier (DI) Information

Brand Name: Pressure Cuff Size 1.6
Version or Model: Pressure Cuff Size 1.6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VIASONIX LTD

Primary DI Number: 07290016880519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533070236 *Terms of Use

Device Description: The intended use of the pressure cuffs is to measure non-invasively blood pressure

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?
34978	Blood pressure cuff, reusable	A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOP	Transducer, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111416	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: 6a98aa0f-b716-4ddb-8c87-8d85973b33e8
Public Version Date: July 07, 2023
Public Version Number: 1
DI Record Publish Date: June 29, 2023