AccessGUDID - DEVICE: OSOM Vaginal Transport Swab Set (00742860100314)

GUDID

Device Identifier (DI) Information

Brand Name: OSOM Vaginal Transport Swab Set
Version or Model: 185
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 185
Company Name: SEKISUI DIAGNOSTICS, LLC

Primary DI Number: 00742860100314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 966812344 *Terms of Use

Device Description: OSOM Vaginal Transport Swab Set

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?
62971	Sexually transmitted infection (STI) testing vaginal specimen collection kit	A collection of sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the vagina for subsequent laboratory analysis and/or other investigations of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae and/or Trichomonas vaginalis]. It includes a transport container with no additives and includes a swab, brush, spatula, and/or other collection devices. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KXG	APPLICATOR, ABSORBENT TIPPED, STERILE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e6af052a-3808-4891-aa56-4c37957595a8
Public Version Date: May 07, 2018
Public Version Number: 1
DI Record Publish Date: April 05, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50742860100319	10	00742860100314		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 10742860100311 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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