AccessGUDID - DEVICE: SurePath Preservative Fluid Collection Vial (10382904905276)

GUDID

Device Identifier (DI) Information

Brand Name: SurePath Preservative Fluid Collection Vial
Version or Model: 490527
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 490527
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382904905276
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 25
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: SurePath® GYN Preservative Vial Kit: 10 mL SurePath® Preservative Fluid Collection Vials (500)

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?
57952	Cytology specimen container IVD, transport buffer	A covered receptacle containing transport buffer solution intended to be used for the collection, preservation, and transport of a cytology specimen (e.g., oral, cervical, colonic) for in vitro diagnostic investigation [e.g., histopathological cervical cancer screening]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	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	002

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
Width: 44.2 Centimeter
Length: 44.2 Centimeter
Height: 8.3 Centimeter

Device Record Status

Public Device Record Key: 50727383-baaf-4989-b37b-20ddaef70346
Public Version Date: January 02, 2023
Public Version Number: 9
DI Record Publish Date: September 08, 2017