AccessGUDID - DEVICE: BD Totalys MultiProcessor (00382904433277)

GUDID

Device Identifier (DI) Information

Brand Name: BD Totalys MultiProcessor
Version or Model: 443327
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 443327
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904433277
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Instrument BD Totalys Multiprocessor

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?
57859	Tissue processor IVD, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKQ	Processor, Cervical Cytology Slide, Automated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970018	032

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55ddcdda-b4f1-4621-8e3b-26013b751f59
Public Version Date: August 23, 2024
Public Version Number: 7
DI Record Publish Date: August 25, 2016