AccessGUDID - DEVICE: Starswab II Bacteriology Culture Collection and Transport System (00840165400181)

GUDID

Device Identifier (DI) Information

Brand Name: Starswab II Bacteriology Culture Collection and Transport System
Version or Model: SP131D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pretium Canada Packaging ULC

Primary DI Number: 00840165400181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 246665038 *Terms of Use

Device Description: Starswab II Bacteriology Culture Collection and Transport System with Amies Charcoal Gel and double plastic shaft rayon tip swab applicators.

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):	No
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?
62773	General specimen collection kit IVD, clinical	A collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIO	Device, Specimen Collection

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: 6b82c6f1-98ed-41f1-a4c2-a80989036fb3
Public Version Date: February 27, 2025
Public Version Number: 1
DI Record Publish Date: February 19, 2025