AccessGUDID - DEVICE: Adview 2® (00634782094010)

GUDID

Device Identifier (DI) Information

Brand Name: Adview 2®
Version or Model: 9005SPDPS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9005SPDPS
Company Name: AMERICAN DIAGNOSTIC CORP

Primary DI Number: 00634782094010
Issuing Agency: GS1
Commercial Distribution End Date: April 19, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 108999095 *Terms of Use

Device Description: Adview2 SpO2 Pediatric Sensor,20 Ped Sensors w/9' Cable

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
16173	Automatic-inflation electronic sphygmomanometer, non-portable	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside.	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 [?]
K160439	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 -4 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5a73075-6531-4d52-865d-623fe931e45f
Public Version Date: November 08, 2019
Public Version Number: 4
DI Record Publish Date: May 11, 2018