AccessGUDID - DEVICE: Well at Walgreens (00311917183404)

GUDID

Device Identifier (DI) Information

Brand Name: Well at Walgreens
Version or Model: WGNBPA-950
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: WGNBPA-950
Company Name: WALGREEN CO.

Primary DI Number: 00311917183404
Issuing Agency: GS1
Commercial Distribution End Date: November 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 008965063 *Terms of Use

Device Description: WALG DLX ARM BP MNTR 2016

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):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
45617	Automatic-inflation electronic sphygmomanometer, portable, arm/wrist	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.	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 Humidity: less than 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 753152.0 Milliliter

Device Record Status

Public Device Record Key: e95fa01b-57fe-464f-975e-7c52d01a0206
Public Version Date: August 14, 2023
Public Version Number: 6
DI Record Publish Date: September 15, 2016