DEVICE: BD Pre-Warm Heater (00382904429508)

Device Identifier (DI) Information

BD Pre-Warm Heater
442950
In Commercial Distribution
442950
BECTON, DICKINSON AND COMPANY
00382904429508
GS1

1
122561087 *Terms of Use
BD Pre-Warm Heater
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Device Characteristics

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

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
Test tube heater An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature.
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FDA Product Code

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Product Code Product Code Name
OOI real time Nucleic acid amplification system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140447 000
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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
Storage Environment Temperature: between 18 and 33 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Depth: 54.4 Centimeter
Width: 29.7 Centimeter
Height: 13 Centimeter
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Device Record Status

f2bc7ae9-ef15-4abc-937f-010194bac242
July 06, 2018
3
May 19, 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
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)638-8663
Technical_services@bd.com
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