FDA.reportPublic FDA data

InSure® ONE™

Primary DI
00850093003347
Brand
InSure® ONE™
Company
ENTERIX INC.
Model
01
Device description
InSure® ONE™ Test Strip: Sold in Vials of 25 Strips (Part Number 12045.01) or in a sealed, bulk pouch of 200 Strips (Part Number 12041.01)
Published
2018-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHEReagent, Occult Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170548000InSure ONEEnterix, Inc.2017-10-05KHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850093003330PackageGS125In Commercial Distribution
00850093003347PackageGS1200In Commercial Distribution
00850093003323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850093003330008500930033308500930033300850093003330
00850093003347008500930033478500930033470850093003347
00850093003323008500930033238500930033230850093003323

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005313681xx@xx.xx

Regulatory Flags#

DUNS number
002224009
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850093003019InSure FIT01800252016-09-20
00850093003040InSure FIT012016-09-20
00850093003187InSure FIT01900022016-10-03
00850093003231InSure® ONE™0180025.012018-01-05
00850093003279InSure® ONE™0190030.012018-01-05
00850093003309InSure® ONE™0190002.012018-01-05
00850093003354InSure® ONE™0190035.012018-01-05
00850093003316InSure® ONE™012018-01-05
00850093003064InSure FIT01150222016-09-14
00850093003033InSure FIT01168002016-09-20
00850093003071InSure FIT01110182016-10-03
00850093003286InSure® ONE™0111018.012018-01-05
00850093003088InSure FIT012016-09-20
00850093003323InSure® ONE™012018-01-05
10850093003085InSure FIT012016-09-20
00850093003095InSure FIT01141032016-09-20
00850093003293InSure® ONE™0114103.012018-01-05
30850093003317InSure® ONE™012018-01-05

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Primary DI, Brand, Company table
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10722355002894hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
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00816862025972WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
10816862025979WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
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