FDA.reportPublic FDA data

InSure FIT

Primary DI
00850093003064
Brand
InSure FIT
Company
ENTERIX INC.
Model
01
Catalog number
15022
Device description
InSure FIT Kit
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K002457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002457000!NSURE FECAL OCCULT BLOOD TESTEnterix, Inc.2001-01-12KHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850093003009PackageGS125In Commercial Distribution
10850093003061PackageGS110In Commercial Distribution
10850093003108PackageGS150In Commercial Distribution
00850093003064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085009300300910850093003009
1085009300306110850093003061
1085009300310810850093003108
00850093003064008500930030648500930030640850093003064

GMDN Terms#

Term, Definition table
TermDefinition
Home faecal specimen collection kitA collection of non-sterile devices and materials intended to be used by a layperson to collect and mail a faecal (stool) sample to a clinical laboratory for diagnostic testing or screening purposes (e.g., occult blood, cytology). The kit includes a specimen container(s), preservative, and other items [e.g., collection assistive device(s), labels, and a container with a requisition form for mailing to the laboratory]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from Heat and Direct Sun Light
Storage Environment Temperature2 Degrees Celsius37 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit99 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002224009
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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
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
00850093003347InSure® ONE™012018-01-05

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Primary DI, Brand, Company table
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10722066011338Rapid ResponseBTNX IncKHE2026-01-02
20722066011335Rapid ResponseBTNX IncKHE2026-01-02
00816917027173OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2025-05-02
10722355002894hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
10722355002900hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
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20850036464666Red TunicaRodimedi & Associates, Inc.KHE2025-03-14
00816862025972WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
10816862025979WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
00816917026374OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2024-06-28
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