DEVICE: Ultracheck (10841522128516)
Device Identifier (DI) Information
Ultracheck
UltraCheck BP Cuffs
In Commercial Distribution
016-1826-02
STATCORP MEDICAL
UltraCheck BP Cuffs
In Commercial Distribution
016-1826-02
STATCORP MEDICAL
BP CUFF, UC ABP NYLON, SM ADULT, 18-26CM, EA
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
---|---|---|---|---|
34978 | Blood pressure cuff, reusable |
A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.
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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 [?] |
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K152801 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 18-26 cm ID |
Device Record Status
d99bbab3-bbf1-4fc1-9453-0f5acc681624
May 28, 2025
17
August 19, 2019
May 28, 2025
17
August 19, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
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