DEVICE: BT37 Incubator (B199GDBT3701ORIGIO0)

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Device Record History
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Device Identifier (DI) Information
BT37 Incubator
GDBT37-01-ORIGIO
In Commercial Distribution

PLANER LIMITED
B199GDBT3701ORIGIO0
HIBCC

1
217190495 *Terms of Use
BT37 Benchtop Incubator - Origio
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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Yes
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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?
44290 Assisted reproduction heater/incubator
An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.
Active false
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FDA Product Code

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Product Code Product Code Name
MQG Accessory, Assisted Reproduction
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K121566 000
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Sterilization
No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Humidity: between 5 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Special Storage Condition, Specify: Recharge every 4 months by connecting to the mains power supply for 24 hours
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
aaf217e0-2db5-47f2-b1c1-879f03651d57
October 28, 2019
4
September 23, 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)

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No
No
None
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Production Identifier(s) in UDI

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No
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No
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Customer Contact

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No Customer Contact currently defined
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