AccessGUDID - DEVICE: BD ProbeTec&#8482; ET Priming and Warming Heater, 120v (00382904404802)

GUDID

Device Identifier (DI) Information

Brand Name: BD ProbeTec™ ET Priming and Warming Heater, 120v
Version or Model: 440480
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 440480
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904404802
Issuing Agency: GS1
Commercial Distribution End Date: June 14, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Priming Warming Heater Blk 100-115V

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46944	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSL	DNA-REAGENTS, NEISSERIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984631	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
No Device Sizes

Device Record Status

Public Device Record Key: 5d517457-6c0f-4ec5-8664-07b386364894
Public Version Date: October 12, 2023
Public Version Number: 4
DI Record Publish Date: May 19, 2016