AccessGUDID - DEVICE: InSure® ONE™ (00850093003316)

GUDID

Device Identifier (DI) Information

Brand Name: InSure® ONE™
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENTERIX INC.

Primary DI Number: 00850093003316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002224009 *Terms of Use

Device Description: InSure® ONE™ Collection Kit: Available in 10-packs (Part Numbers 15022.01, 15027.01, 15240.01, and 90010.01), 25-packs (Part Number 90025.01) and 50-packs (15030.01, 15040.01, and 90050.01)

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?
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 [?]
K170548	000

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
Storage Environment Temperature: between 2 and 37 Degrees Celsius
Special Storage Condition, Specify: Protect from Heat and Direct Sun Light
Storage Environment Temperature: between 36 and 99 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c369247-d45a-4ba2-880e-d021c15d4ddc
Public Version Date: April 08, 2022
Public Version Number: 8
DI Record Publish Date: January 05, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
30850093003317	50	00850093003316	In Commercial Distribution	Case
20850093003310	25	00850093003316	In Commercial Distribution	Case
10850093003313	10	00850093003316	In Commercial Distribution	Case