DEVICE: Diagnostix™ (00634782083106)

Device Identifier (DI) Information

Diagnostix™
774-12XDH
In Commercial Distribution
774-12XDH
AMERICAN DIAGNOSTIC CORP
00634782083106
GS1

1
108999095 *Terms of Use
PROSPHYG SPU Sphyg,Large Adult
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
DXQ Blood Pressure Cuff
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Large Adult, 31-40cm
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Device Record Status

fe1a0b26-e0a6-4013-8630-2bc4cf86ace3
March 29, 2018
2
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00634782584481 5 00634782884482 In Commercial Distribution Master Case
00634782884482 5 00634782083106 In Commercial Distribution Inner Pack
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-800-232-2670
info@adctoday.com
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