AccessGUDID - DEVICE: hema-screen Mailing Envelopes (10722355002122)

GUDID

Device Identifier (DI) Information

Brand Name: hema-screen Mailing Envelopes
Version or Model: HSME-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IMMUNOSTICS COMPANY, INC

Primary DI Number: 10722355002122
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 119214195 *Terms of Use

Device Description: Fecal Occult Blood Reagent, Guaiac

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:	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?
61352	Faecal specimen collection kit IVD, home-use	A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHE	REAGENT, OCCULT BLOOD

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: 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: 3350e66a-d5b1-4e54-9169-b5f694738a23
Public Version Date: April 08, 2022
Public Version Number: 7
DI Record Publish Date: September 23, 2016