AccessGUDID - DEVICE: Sample Preparation System (Stool) (00404847456745)

GUDID

Device Identifier (DI) Information

Brand Name: Sample Preparation System (Stool)
Version or Model: EIA-5674
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-5674
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 00404847456745
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

Device Description: A collection of devices intended to be used for the collection, preservation, and transport of any type of clinical specimen from any body part.

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?
65306	General specimen collection kit IVD, no additive	A collection of devices intended to be used for the collection, preservation, and transport of any type of clinical specimen (e.g., faeces, sputum, mucous, wound exudate, vaginal secretion) collected from any body part [e.g., natural orifice, skin (i.e., it is not dedicated to a body region)] for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture, histopathology, microscopy]. It includes a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a closable plastic receptacle with no additive. This a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NNK	CONTAINER, SPECIMEN MAILER AND STORAGE, NON-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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f4cf12c9-7e52-4c04-88ca-768bc22ea07c
Public Version Date: June 15, 2021
Public Version Number: 1
DI Record Publish Date: June 07, 2021