AccessGUDID - DEVICE: BD Microprobe™ Processor (00382902119180)

GUDID

Device Identifier (DI) Information

Brand Name: BD Microprobe™ Processor
Version or Model: 211918
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 211918
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902119180
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Microprobe™ Processor

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?
48030	Isothermal nucleic acid amplification analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen at a constant (isothermal) temperature, using a series of transcription and reverse transcription reactions, and to detect and/or identify the amplified product using oligonucleotide markers as it is produced (e.g., in real-time).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQW	STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923268	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 -20 and 65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 16 Centimeter
Width: 26 Centimeter
Depth: 24 Centimeter

Device Record Status

Public Device Record Key: 63678a2e-e38c-4155-863b-1f9b6fe89fcd
Public Version Date: August 28, 2024
Public Version Number: 5
DI Record Publish Date: May 25, 2018