DEVICE: Henry Schein (00304040001882)
Device Identifier (DI) Information
Henry Schein
1126090
In Commercial Distribution
1126090
HENRY SCHEIN, INC.
1126090
In Commercial Distribution
1126090
HENRY SCHEIN, INC.
ProPlus Cuff & Bladder, 1 Tube, Child, Black
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
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Device Size Text, specify: Child, 13-19.5cm |
Device Record Status
d4812acf-8a13-4ebb-a940-95fa7a041c3a
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10304040001889 | 15 | 00304040001882 | In Commercial Distribution | Master Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined