AccessGUDID - DEVICE: NIBP Cuffs (00884838114692)

GUDID

Device Identifier (DI) Information

Brand Name: NIBP Cuffs
Version or Model: COMFORT CARE CUFF, ADULT XL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M1574XL
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838114692
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: Comfort Care Cuff, Adult Long (navy blue w/edge striping). Limb circumference 27-35cm. Reusable 2-piece cuff with removable bladder. Quantity 1 cuff.

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
DSI	DETECTOR AND ALARM, ARRHYTHMIA

FDA Premarket Submission

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

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 Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Circumference: 35.0000 Centimeter
Device Size Text, specify: Circumference 35 Centimetre

Device Record Status

Public Device Record Key: cb336aa1-6125-4b01-9a2e-28931a17166d
Public Version Date: September 16, 2025
Public Version Number: 2
DI Record Publish Date: March 23, 2025