DEVICE: Kryo 360 Freezer (B199GDKRYO360171150)

Device Identifier (DI) Information

Kryo 360 Freezer
GDKRYO360-1.7-115
In Commercial Distribution

PLANER PLC
B199GDKRYO360171150
HIBCC

1
217190495 *Terms of Use
Kryo 360 Controlled Rate Freezer. 1.7 Litre Chamber
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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

GMDN Preferred Term Name GMDN Definition
Freezer control unit, programmable A mains electricity (AC-powered) unit used together with a specific freezer where it is important that a certain predetermined freezing pattern is followed in order to preserve the contents of the freezer. This pattern may differ according to various considerations, e.g., lowering of temperature by steps over a given time. A pre-set program will be imposed upon the freezer.
Assisted reproduction freezer A mains electricity (AC-powered) device designed to provide suitable cold storage conditions for reproductive biological materials (e.g., gametes, embryos) at closely regulated and monitored temperatures. It will typically use liquid nitrogen (LN2) to create cold temperatures, as well as an electrical heater and air circulating fan for temperature control. It will typically have an integral alarm system to warn against temperature variations and breaks in the mains power supply. This device is typically not intended for long-term storage.
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FDA Product Code

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Product Code Product Code Name
KSP Apparatus, Cell-Freezing And Reagents
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
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
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

5bd1dcc4-5531-4b9a-90d8-20e451b20e24
March 29, 2018
2
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
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None
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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No Customer Contact currently defined
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