FDA.reportPublic FDA data

Simple HealthKit

Primary DI
00850066710272
Brand
Simple HealthKit
Company
SIMPLE HEALTHKIT, INC.
Model
1
Published
2026-01-21
Public version status
New
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
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850066710272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850066710272008500667102728500667102720850066710272

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection paperA non-sterile filter-paper card intended to be used as a medium for the collection and transport of blood specimen spots to a laboratory for testing. It provides a uniform surface for the collection of blood spot specimens taken from the patient. Also known as an Ahlstrom 226 specimen collection paper or a Whatman body fluid collection paper, it may incorporate a tear-apart form for demographic information. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117058089
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04779054721273RDA SpotRDA SPOT, UABPQD2026-08-14
04779054721549PulsettoRDA SPOT, UABPQD2026-08-14
00810111410038LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410052LetsGetChecked Blood Sample Collection Kit (HCV)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410182LetsGetChecked Blood Sample Collection Kit (MHTP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410199LetsGetChecked Blood and Saliva Sample Collection Kit (MHTPC)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410205LetsGetChecked Blood Sample Collection Kit (MHTP)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410250LetsGetChecked Blood Sample Collection Kit (ANMH2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410366LetsGetChecked Blood Sample Collection Kit (TRFNUS+)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410540LetsGetChecked Blood Sample Collection Kit (GLCS)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410557LetsGetChecked Blood Sample Collection Kit (LEAD)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410588LetsGetChecked Blood Sample Collection Kit (HPSP)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410649LetsGetChecked Blood Sample Collection Kit (OBIOMVA & OBIOMV)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410694LetsGetChecked Blood Sample Collection Kit (EWB1)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410700LetsGetChecked Blood Sample Collection Kit (EDB1)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410793LetsGetChecked Blood Sample Collection Kit (KDRN)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410816LetsGetChecked Blood Sample Collection Kit (CDST1)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410908LetsGetChecked Blood and Saliva Sample Collection Kit (PCOS3)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850024881877LetsGetChecked Blood Sample Collection Kit (BIOM)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850024881884LetsGetChecked Blood Sample Collection Kit (BIOM4)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850024881952LetsGetChecked Blood Sample Collection Kit (GLCSLIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850038691172Tasso+ Standard KitTasso Inc.PQD2026-07-06
00850038691189Tasso Mini Standard KitTasso Inc.PQD2026-07-06
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220803BASELINE Venous Sample Collection kitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
00850024881860LetsGetChecked Blood Sample Collection Kit (BIOM2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-05-06
00810010895011Aero-MedAERO-MED, LLCPQD2026-05-04