AccessGUDID - DEVICE: BD PrepStain™ Consumables Kit (00382904913113)

GUDID

Device Identifier (DI) Information

Brand Name: BD PrepStain™ Consumables Kit
Version or Model: 491311
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 491311
Company Name: TRIPATH IMAGING, INC.

Primary DI Number: 00382904913113
Issuing Agency: GS1
Commercial Distribution End Date: October 26, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 103318015 *Terms of Use

Device Description: BD PrepStain™ Consumables Kit: BD SurePath™ PreCoat Slides (5 X 96), BD PrepStain™ Transfer Tips (5 X 96), & BD Settling Chambers (2 X 240)

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
12955	Papanicolaou smear kit	A packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device.	Obsolete	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	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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe675f36-810c-4888-9f97-c032fc0a1dec
Public Version Date: October 26, 2020
Public Version Number: 5
DI Record Publish Date: September 08, 2017