DEVICE: Henry Schein (00304040001684)
Device Identifier (DI) Information
Henry Schein
1126074
In Commercial Distribution
1126074
HENRY SCHEIN, INC.
1126074
In Commercial Distribution
1126074
HENRY SCHEIN, INC.
Pro Pocket Sphyg, Thigh, Black
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXQ | blood pressure cuff |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
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Device Size Text, specify: Thigh, 40-66cm |
Device Record Status
4a2cd316-2976-4132-acce-1b97c877604a
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 |
---|---|---|---|---|---|
10304040001681 | 12 | 00304040001684 | 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