FDA.reportPublic FDA data

InSure® ONE™

Primary DI
30850093003317
Brand
InSure® ONE™
Company
ENTERIX INC.
Model
01
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)
Published
2018-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10850093003313PackageGS110In Commercial Distribution
20850093003310PackageGS125In Commercial Distribution
30850093003317PackageGS150In Commercial Distribution
00850093003316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085009300331310850093003313
2085009300331020850093003310
3085009300331730850093003317
00850093003316008500930033168500930033160850093003316

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

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
true
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
00850093003347InSure® ONE™012018-01-05

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