AccessGUDID - DEVICE: DHI Specimen Collection System (30014613335443)

GUDID

Device Identifier (DI) Information

Brand Name: DHI Specimen Collection System
Version or Model: 99-08012.V2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 99-08012.V2
Company Name: DIAGNOSTIC HYBRIDS, INC.

Primary DI Number: 30014613335443
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117359612 *Terms of Use

Device Description: KIT, MALE WITH UTM

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?
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
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: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fdf94f2e-7a20-4e2d-821f-5075d3d8bece
Public Version Date: June 29, 2023
Public Version Number: 6
DI Record Publish Date: November 28, 2018