FDA.reportPublic FDA data

FOLLISTIM AQ CARTRIDGE 300IU

Primary DI
00378206129017
Brand
FOLLISTIM AQ CARTRIDGE 300IU
Company
Organon LLC
Model
1044615
Published
2024-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162516000BD Pen NeedleBecton, Dickinson and Company2016-12-09FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60378206129019PackageGS124In Commercial Distribution
00378206129017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6037820612901960378206129019
00378206129017003782061290173782061290170378206129017

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge29Gauge

Contacts#

Phone, Email table
PhoneEmail
+1(844)674-3200dpoc.us@organon.com

Regulatory Flags#

DUNS number
117494753
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10378206189018XACIATO10482282024-09-13
00840164519440FOLLISTIM PEN STARTER KIT10449422024-01-01
00840164519457FOLLISTIM PEN STARTER KIT SAM10449432024-01-01
00378206129598FOLLISTIM AQ CARTRIDGE 300IU SAM10448012024-01-01
00378206130013FOLLISTIM AQ CARTRIDGE 600IU10446162024-01-01
00378206130594FOLLISTIM AQ CARTRIDGE 600IU SAM10448002024-01-01
00378206131010FOLLISTIM AQ CARTRIDGE 900IU10446172024-01-01
60378206129019FOLLISTIM AQ CARTRIDGE 300IU10446152024-01-01
60378206129590FOLLISTIM AQ CARTRIDGE 300IU SAM10448012024-01-01
60378206130015FOLLISTIM AQ CARTRIDGE 600IU10446162024-01-01
60378206130596FOLLISTIM AQ CARTRIDGE 600IU SAM10448002024-01-01
60378206131012FOLLISTIM AQ CARTRIDGE 900IU10446172024-01-01
60840164519442FOLLISTIM PEN STARTER KIT10449422024-01-01
60840164519459FOLLISTIM PEN STARTER KIT SAM10449432024-01-01
00840164521139JADA SystemJADA-20022023-02-15
60840164521131JADA SystemJADA-20022023-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20357515755043UltiCareULTIMED, INC.FMI2026-10-23
16972857299337Pen Needles ClassicSandstone Medical (Suzhou) Inc.FMI2026-10-11
16972857299290Easydrip Readygard DuoSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299306Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
16972857299313Easydrip ReadygardSandstone Medical (Suzhou) Inc.FMI2026-10-09
00050428167243TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
00050428167267TRUEplusTRIVIDIA HEALTH, INC.FMI2026-10-07
06958697621821One+Step INSULIN PEN NEEDLEANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTDFMI2026-10-01
M99230402912120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
M99230403250120LCH3Livaclean HealthCarelife (usa) Inc.FMI2026-09-30
00850002860733Comfort EZ Pro DuoS.D.I. USA, INC.FMI2026-09-28
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252Pen NeedlesSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070037CoreCareCorecare Products Inc.FMI2026-09-11
00850091070051CoreCareCorecare Products Inc.FMI2026-09-11
00850091070068CoreCareCorecare Products Inc.FMI2026-09-11
00850091070099CoreCareCorecare Products Inc.FMI2026-09-11
00850091070112CoreCareCorecare Products Inc.FMI2026-09-11
00850091070136CoreCareCorecare Products Inc.FMI2026-09-11
00850091070150CoreCareCorecare Products Inc.FMI2026-09-11
00850091070174CoreCareCorecare Products Inc.FMI2026-09-11
00850091070198CoreCareCorecare Products Inc.FMI2026-09-11
00850091070228CoreCareCorecare Products Inc.FMI2026-09-11
00850091070471CoreCareCorecare Products Inc.FMI2026-09-11