AccessGUDID - DEVICE: BD PrepMate™ Automated Accessory (00382904911034)

GUDID

Device Identifier (DI) Information

Brand Name: BD PrepMate™ Automated Accessory
Version or Model: 491103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 491103
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904911034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD PrepMate™ Automated Accessory (100-240V)

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	028

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 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Depth: 23 Inch
Height: 22 Inch
Width: 14 Inch

Device Record Status

Public Device Record Key: 3e676f48-29e1-450a-b600-ea19378a6b04
Public Version Date: March 13, 2025
Public Version Number: 7
DI Record Publish Date: September 08, 2017