AccessGUDID - DEVICE: SOFT-CUF (00840682105620)

GUDID

Device Identifier (DI) Information

Brand Name: SOFT-CUF
Version or Model: SFT-F1-2A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ge Medical Systems Information Technologies, Inc.

Primary DI Number: 00840682105620
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118935631 *Terms of Use

Device Description: SOFT-CUF, RADIAL, DINACLICK, 26 - 36 CM, SINGLE

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):	Yes
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
DXQ	blood pressure cuff

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123996	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
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Forearm

Device Record Status

Public Device Record Key: de3a1973-0c24-412d-91e5-fa2d257830a3
Public Version Date: May 08, 2025
Public Version Number: 6
DI Record Publish Date: June 30, 2016