AccessGUDID - DEVICE: Stool Collection Aid (04262389480026)

GUDID

Device Identifier (DI) Information

Brand Name: Stool Collection Aid
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Fecescatcher
Company Name: Med Auxil analysis aids e.K.

Primary DI Number: 04262389480026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 315109219 *Terms of Use

Device Description: Product description: Paper products for safe and hygienic preparation of stool samples with imprinted description for handling. Easy to unfold and intended for mounting on the lavatory seat using its external removable adhesive. In addition, upon unfolding an inner adhesive forms a collection trough which prevents liquid stool from sliding off into the toilet thereby ensuring safe collection of the sample. Materials and manufacturing processes are based on up-to-date environmental criteria. This ensures that the paper and adhesive do not generate any waste water pollution upon disposal. Scope of application: stool sampling, stool inspection. Container package information: Package UDI-DI: 04262389480675 GS1, Quantity per package: 2, Calculated number of devices: 2. Package UDI-DI: 04262389480682 GS1, Quantity per package: 500, Calculated number of devices: 1000.

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?
15743	Specimen container mailer, insulated	A non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection and insulation for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities. It includes insulation intended to provide a thermal barrier between the specimen and the environment to preserve temperature-sensitive samples. The device is also intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.	Active	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 5 and 35 Degrees Celsius
Handling Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ae2d0d4-73a2-4e55-8bd6-4991fad3b891
Public Version Date: March 07, 2024
Public Version Number: 1
DI Record Publish Date: February 28, 2024