AccessGUDID - DEVICE: BD SurePath™ Preservative Fluid (00382904913373)

GUDID

Device Identifier (DI) Information

Brand Name: BD SurePath™ Preservative Fluid
Version or Model: 491337
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 491337
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904913373
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD SurePath™ Preservative Fluid (3600mL)

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:	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?
57743	Cytology fixative solution IVD	An alcohol-based solution intended to be used as a fixative for a cytology specimen obtained directly from a patient, or processing of a clinical specimen, for subsequent preservation, transportation and/or in vitro diagnostic analysis.	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	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: 0781fd88-122e-4e75-b026-55a7de4edf57
Public Version Date: September 23, 2024
Public Version Number: 6
DI Record Publish Date: September 08, 2017