DEVICE: BioButton At-Home Kit with Power Adaptor (00850005949312)

Device Identifier (DI) Information

BioButton At-Home Kit with Power Adaptor
KIT-BBR-3763-1
In Commercial Distribution

BIOINTELLISENSE, INC.
00850005949312
GS1

1
116984478 *Terms of Use
BioButton At-Home Kit with Power Adaptor
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
Yes
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?
12391 Wearable multiple physiological parameter recorder, reusable
An electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K212957 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

db45fb3c-9ce7-4d71-9968-71cb2dd4604c
November 24, 2023
1
November 16, 2023
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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
00850005949336 50 00850005949312 In Commercial Distribution Master Carton (MC)
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Secondary DI

[?]
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
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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