AccessGUDID - DEVICE: BD Totalys™ SlidePrep Slide Library Kit (00382904913885)

GUDID

Device Identifier (DI) Information

Brand Name: BD Totalys™ SlidePrep Slide Library Kit
Version or Model: 491388
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 491388
Company Name: TRIPATH IMAGING, INC.

Primary DI Number: 00382904913885
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103318015 *Terms of Use

Device Description: No description.

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970018	030

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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 316d57b0-eae4-4e9d-90e3-e388256ed554
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 23, 2016