AccessGUDID - DEVICE: CARDINAL HEALTH (50885380021884)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 30503319SA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 30503319SA
Company Name: Cardinal Health 200, LLC

Primary DI Number: 50885380021884
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2020
Device Count: 20
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Blood Pressure Cuff w/Bayonet Connect, One Tube, Disp, Sm Child

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":	Yes
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?
37326	Blood pressure cuff, single-use	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 typically wrapped around the upper arm of the patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXQ	blood pressure cuff

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 62f302c3-f1d4-4397-a239-0c1cb542f1e9
Public Version Date: December 31, 2020
Public Version Number: 7
DI Record Publish Date: September 15, 2016