DEVICE: BD PrepStain Slide Processor (00382904904104)

Device Identifier (DI) Information

BD PrepStain Slide Processor
490410
Not in Commercial Distribution
490410
TRIPATH IMAGING, INC.
00382904904104
GS1
May 17, 2017
1
103318015 *Terms of Use
BD PrepMate™ Automated Accessory (115V)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

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.
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FDA Product Code

[?]
Product Code Product Code Name
MKQ Processor, Cervical Cytology Slide, Automated
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P970018 002
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Depth: 23 Inch
Width: 12.5 Inch
Height: 21 Inch
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Device Record Status

f43f8681-634d-4020-9264-a5e7d4f0769d
July 06, 2018
3
July 22, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
1-800-638-8663
technical_services@bd.com
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