FDA.reportPublic FDA data

InSure® ONE™

Primary DI
00850093003354
Brand
InSure® ONE™
Company
ENTERIX INC.
Model
01
Catalog number
90035.01
Device description
InSure® ONE™ Combo Pack - contains 35 Collection Kits and 1 Developer Kit
Published
2018-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00850093003354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850093003354008500930033548500930033540850093003354

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 Celsius25 Degrees Celsius
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
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
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
00850093003347InSure® ONE™012018-01-05

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10816862025979WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
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