DEVICE: Actiheart (B329AH420)

Device Identifier (DI) Information

Actiheart
AH4
In Commercial Distribution
08-305
CAMNTECH LIMITED
B329AH420
HIBCC

1
399114941 *Terms of Use
Ambulatory ECG recorder with acclerometer - single channel
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrocardiographic long-term ambulatory recorder, telemetric An automated, battery-powered, device intended to be used for the 24-hour registration of a patient's heart activity and the wireless transmission of the registered electrocardiogram (ECG) to a receiver/analysis system. The patient is connected to and wears the device during the recording period and/or while he or she performs normal daily activities. The recording is analysed at a medical facility using an electrocardiographic Holter analyser or a computer, with dedicated software.
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FDA Product Code

[?]
Product Code Product Code Name
GWK Conditioner, Signal, Physiological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052489 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

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Size Type Text
No Device Sizes
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Device Record Status

96e75109-6645-4035-ba26-c2651f598f6f
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1 830-755-8036
sales@camntech.com
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