AccessGUDID - DEVICE: Easy Stool Extraction Device (B24230EZEX1000)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Stool Extraction Device
Version or Model: 30-EZEX-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30-EZEX-100
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24230EZEX1000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: The ALPCO Easy Stool Extraction Device is intended for the storage and preparation of human stool samples for examination. For In Vitro Diagnostic Use.

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?
62669	Clinical specimen extraction buffer IVD	A buffered solution intended to be used for the processing and preparation of a clinical specimen, for subsequent in vitro diagnostic testing, by extraction of specific target analytes present in the clinical specimen (e.g., proteins, antigens).	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1113caae-13ee-4e77-b4fe-0132faf5f889
Public Version Date: November 06, 2020
Public Version Number: 2
DI Record Publish Date: July 17, 2020