AccessGUDID - DEVICE: InSure® ONE™ (00850093003286)

GUDID

Device Identifier (DI) Information

Brand Name: InSure® ONE™
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11018.01
Company Name: ENTERIX INC.

Primary DI Number: 00850093003286
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002224009 *Terms of Use

Device Description: InSure® ONE™ Test Cards for QC - 50 pack

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?
38218	Faecal occult blood IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin).	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
Storage Environment Temperature: between 36 and 99 Degrees Fahrenheit
Special Storage Condition, Specify: Protect from heat and direct sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0caaf68-9b44-477e-a005-f872d5110b1b
Public Version Date: April 06, 2020
Public Version Number: 4
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 Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18005313681
Email: xx@xx.xx

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES