AccessGUDID - DEVICE: BD Pre-Warm Heater (00382904429508)

GUDID

Device Identifier (DI) Information

Brand Name: BD Pre-Warm Heater
Version or Model: 442950
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 442950
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904429508
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Pre-Warm Heater

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

FDA Product Code

[?]

Product Code	Product Code Name
OOI	real time Nucleic acid amplification system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140447	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 18 and 33 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Depth: 54.4 Centimeter
Width: 29.7 Centimeter
Height: 13 Centimeter

Device Record Status

Public Device Record Key: f2bc7ae9-ef15-4abc-937f-010194bac242
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 19, 2016