AccessGUDID - DEVICE: NIBP, Disposable, Large Adult, 35-45cm (00884838034334)

GUDID

Device Identifier (DI) Information

Brand Name: NIBP, Disposable, Large Adult, 35-45cm
Version or Model: Cuff, NIBP, Disp, Large Adult, 35-45cm
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 989803170481
Company Name: Philips Ds North America LLC

Primary DI Number: 00884838034334
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 013649151 *Terms of Use

Device Description: NiBP, Disp, Large Adult, 35 - 45

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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 Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85e8c7b5-3d34-4c45-8c17-2e225081fe8b
Public Version Date: February 01, 2024
Public Version Number: 9
DI Record Publish Date: September 29, 2016