DEVICE: Claricuff™ (B593CSST2635HP0)

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Device Record History
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Device Identifier (DI) Information
Claricuff™
Tapmedic
In Commercial Distribution

Ningbo Albert Novosino Co.,Ltd.
B593CSST2635HP0
HIBCC
March 22, 2028
1
543014978 *Terms of Use
Claricuff™ Non-Invasive Blood Pressure Cuffs and Accessories
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
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?
37326 Blood pressure cuff, single-use
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 typically wrapped around the upper arm of the patient. This is a single-use device.
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 [?]
K173044 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
3c901b89-c932-4f98-916b-596dc62d4480
July 06, 2018
2
March 22, 2018
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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
No Package DIs found
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Secondary DI

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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
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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