AccessGUDID - DEVICE: Hopkins (00634782048969)

GUDID

Device Identifier (DI) Information

Brand Name: Hopkins
Version or Model: 700XHOP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 700XHOP
Company Name: AMERICAN DIAGNOSTIC CORP

Primary DI Number: 00634782048969
Issuing Agency: GS1
Commercial Distribution End Date: April 11, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 108999095 *Terms of Use

Device Description: Premium Aneroid Sphyg,Lrg Adult, Black, HOP PL

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?
16156	Aneroid manual sphygmomanometer	A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope.	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 Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Large Adult, 34-50cm

Device Record Status

Public Device Record Key: 88f9aebe-800f-4494-9040-298033f27c78
Public Version Date: April 12, 2019
Public Version Number: 3
DI Record Publish Date: July 21, 2017