FDA.reportPublic FDA data

Truepill Inc.

Primary DI
00850032976107
Brand
Truepill Inc.
Company
Postmeds, Inc.
Model
1
Published
2022-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032976107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032976107008500329761078500329761070850032976107

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection kit, home-useA collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080974592
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850032976114Truepill Inc.12022-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380213960Aero-MedAERO-MED, LLCOIB2026-10-07
10885380213953Aero-MedAERO-MED, LLCOIB2026-10-06
10885380193002Aero-MedAERO-MED, LLCOIB2026-09-29
10192253057591Aero-MedAERO-MED, LLCOIB2026-09-28
10192253063226Aero-MedAERO-MED, LLCOIB2026-09-28
10192253063332Aero-MedAERO-MED, LLCOIB2026-09-28
10192253066760Aero-MedAERO-MED, LLCOIB2026-09-28
10192253067644Aero-MedAERO-MED, LLCOIB2026-09-28
10885380185045Aero-MedAERO-MED, LLCOIB2026-09-28
10885380185052Aero-MedAERO-MED, LLCOIB2026-09-28
10885380187889Aero-MedAERO-MED, LLCOIB2026-09-28
10885380190261Aero-MedAERO-MED, LLCOIB2026-09-28
10885380190988Aero-MedAERO-MED, LLCOIB2026-09-28
10885380195822Aero-MedAERO-MED, LLCOIB2026-09-28
10885380196812Aero-MedAERO-MED, LLCOIB2026-09-28
10885380196829Aero-MedAERO-MED, LLCOIB2026-09-28
10885380200601Aero-MedAERO-MED, LLCOIB2026-09-28
10885380200823Aero-MedAERO-MED, LLCOIB2026-09-28
10885380200830Aero-MedAERO-MED, LLCOIB2026-09-28
10885380200892Aero-MedAERO-MED, LLCOIB2026-09-28
10885380202841Aero-MedAERO-MED, LLCOIB2026-09-28
10885380203169Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206559Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206566Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206573Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206580Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206597Aero-MedAERO-MED, LLCOIB2026-09-28
10885380207662Aero-MedAERO-MED, LLCOIB2026-09-28
10885380208836Aero-MedAERO-MED, LLCOIB2026-09-28
10885380213939Aero-MedAERO-MED, LLCOIB2026-09-28