FDA.reportPublic FDA data

Doselogix

Primary DI
00813360021994
Brand
Doselogix
Company
TEAM TECHNOLOGIES, INC.
Model
TCPERL01
Catalog number
752645
Device description
DOSELOGIX TCPERL01 35ML PERL VAGINAL DOSING SYSTEM
Published
2022-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
HGDApplicator, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGDApplicator, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813360021991PackageGS125In Commercial Distribution
20813360021998PackageGS110In Commercial Distribution
00813360021994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081336002199110813360021991
2081336002199820813360021998
00813360021994008133600219948133600219940813360021994

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal applicator, single-useA device designed to apply medication to the vagina. It is typically a simple rod, blade, spatula, or paddle. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature35 Degrees Fahrenheit160 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078550672
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813360023233DoselogixTC5-A-BLUE7557452026-05-05
00813360023639DoselogixTC5-A-LSPR-3.5ML 6.5ML Micro7557752026-03-24
00813360023240DoselogixTC5-A-RED7557472025-06-05
00813360023257DoselogixTC5-A-BLUE7557482025-06-05
00813360023226DoselogixTC9-A-LIGHTSAFE-6.5ML ANGLED7557432025-05-12
00813360023189DoselogixTC35-CRTC35-CR-BLUE2025-08-01
00813360023196DoselogixTC35-CRTC35-CR-PINK2025-08-01
00813360023202DoselogixTC35-CRTC35-CR-GREY2025-08-01
00813360023219DoselogixTC35-CRTC35-CR-White2025-08-01
00813360023172DoselogixDOSE LOGIX TC5-A-RED 3.5ML7557412025-04-21
00813360023158DoselogixTC35-CHKTC35-CHK-BLUE2025-02-25
00813360023165DoselogixTC35-CHKTC35-CHK-PINK2025-02-25
00813360023554DoselogixTC9-A-BLUE 3.5ML Micro7556232024-08-13
00813360023561DoselogixTC9-A-BLUE 6.5ML Micro7556242024-08-13
00813360023578DoselogixTC9-A-LIGHTSAFE 3.5ML Micro7556252024-08-13
00813360023585DoselogixTC9-A-LIGHTSAFE 6.5ML Micro7556262024-08-13
00813360023592DoselogixTC9-R-BLUE 3.5ML Micro7556272024-08-13
00813360023608DoselogixTC9-R-BLUE 6.5ML Micro7556282024-08-13
00813360023615DoselogixTC9-R-LIGHTSAFE 3.5ML Micro7556292024-08-13
00813360023622DoselogixTC9-R-LIGHTSAFE 6.5ML Micro7556302024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015433701WandahCASCO BAY MOLDING LTD.HGD2026-05-15
00841445001388Diva Biome Balancer ApplicatorDiva International IncHGD2026-02-06
10378206189018XACIATOOrganon LLCHGD2024-09-13
00860012119363ReiaReia, LLCHGD2024-07-22
00860012119370ReiaReia, LLCHGD2024-07-22
00860012119387ReiaReia, LLCHGD2024-07-22
00850016867377Pixie CupPixie Cup LLCHGD2023-11-20
00850016867728Pixie CupPixie Cup LLCHGD2023-11-20
00719113275860Vaginal ApplicatorMai/GenesisHGD2023-09-14
00338779998410Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00338779998427Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00338779998434Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998417Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998424Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998431Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00860009492905VCA LitePce, Inc.HGD2023-08-11
00860009492912VCA LitePce, Inc.HGD2023-08-11
00826804000516Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804000523Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804000530Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006914Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006938Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006945Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006952Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00813360022076DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-07
10813360022073DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-07
00813360022069DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-01
08057509880031NAINGE SPAHGD2022-07-17
08057509880024NAINGE SPAHGD2022-07-17
00653160055733CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHGD2022-01-02