DEVICE: Microlife (04719003315085)

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Device Record History
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Device Identifier (DI) Information
Microlife
CRO-BP3MX1-3C1
In Commercial Distribution

MICROLIFE USA, INC.
04719003315085
GS1

1
176387785 *Terms of Use
WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
64511 Arrythmia-detection sphygmomanometer
An electrically-powered device designed to noninvasively measure blood pressure and, in addition, detect cardiac arrythmias [e.g., atrial fibrillation (AF)] by automatically inflating and deflating a cuff that typically fits around a limb (arm or thigh); it may also measure the heart rate and mean arterial pressure. It typically incorporates a display and controls, and may include a blood pressure cuff with connection tubing. The measurements may be analysed at a medical facility, typically using a computer or mobile phone with a dedicated software.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DXN System, Measurement, Blood-Pressure, Non-Invasive
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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
21a94dda-8265-4698-a149-b20806712cbd
March 19, 2025
1
March 11, 2025
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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
14719003315082 1 04719003315085 In Commercial Distribution Gift box
24719003315089 4 14719003315082 In Commercial Distribution Inner box
34719003315086 8 24719003315089 In Commercial Distribution Carton
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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

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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
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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