DEVICE: Self-Taking Blood Pressure Kit -Standard Adult Size Cuff (00073796010409)
Device Identifier (DI) Information
Self-Taking Blood Pressure Kit -Standard Adult Size Cuff
0104
In Commercial Distribution
Omron Healthcare, Inc.
0104
In Commercial Distribution
Omron Healthcare, Inc.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
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 [?] |
---|---|
K780715 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8dcd7e0c-85d4-4899-9771-1684ddffa30e
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 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 |
---|---|---|---|---|---|
10073796010406 | 12 | 00073796010409 | In Commercial Distribution | Inner Carton | |
20073796010403 | 2 | 10073796010406 | In Commercial Distribution | 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
[?]
1-800-634-4350
ohiquality@omron.com
ohiquality@omron.com