AccessGUDID - DEVICE: Adtoons™ (00634782057251)

GUDID

Device Identifier (DI) Information

Brand Name: Adtoons™
Version or Model: 860GAR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 860GAR
Company Name: AMERICAN DIAGNOSTIC CORP

Primary DI Number: 00634782057251
Issuing Agency: GS1
Commercial Distribution End Date: April 18, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 108999095 *Terms of Use

Device Description: ADTOONS Inflation System,Adult, Garfield

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:	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
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
Storage Environment Temperature: between -4 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Adult, 23-40cm

Device Record Status

Public Device Record Key: 024af57b-8fed-4b21-82f1-197a08b0020a
Public Version Date: July 22, 2019
Public Version Number: 4
DI Record Publish Date: September 21, 2016