FDA.reportPublic FDA data

FOLLISTIM PEN STARTER KIT

Primary DI
00840164519440
Brand
FOLLISTIM PEN STARTER KIT
Company
Organon LLC
Model
1044942
Published
2024-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSCINJECTOR, PEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSCInjector, PenGeneral 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
60840164519442PackageGS112In Commercial Distribution
00840164519440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6084016451944260840164519442
00840164519440008401645194408401645194400840164519440

GMDN Terms#

Term, Definition table
TermDefinition
Empty self-injector, mechanicalA portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. A dial on the injector is operated for dosing (e.g., via a spring-loaded mechanism). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.25Inch

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
00840164519457FOLLISTIM PEN STARTER KIT SAM10449432024-01-01
00378206129017FOLLISTIM AQ CARTRIDGE 300IU10446152024-01-01
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
00840164519457FOLLISTIM PEN STARTER KIT SAMOrganon LLCNSC2024-01-01
60840164519442FOLLISTIM PEN STARTER KITOrganon LLCNSC2024-01-01
60840164519459FOLLISTIM PEN STARTER KIT SAMOrganon LLCNSC2024-01-01
57622436000010Omnitrope® Pen 10Sandoz Inc.NSC2023-10-05
57622436000027Omnitrope® Pen 5Sandoz Inc.NSC2023-10-05
57612799210546Omnitrope Pen 10Sandoz GmbHNSC2023-02-07
59002269207349Omnitrope Pen 5Sandoz GmbHNSC2023-02-07
47612799222856Omnitrope Pen 10Sandoz GmbHNSC2023-02-07
47612799222849Omnitrope Pen 5Sandoz GmbHNSC2023-02-07
49002269218553Omnitrope Pen 10Sandoz GmbHNSC2023-02-07
00358406480019AutoTouch Connect reusable autoinjectorAMGEN INC.NSC2021-11-08
10358406480016AutoTouch Connect reusable autoinjectorAMGEN INC.NSC2021-11-08
00015482272531Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 100'sARKRAY USA, INC.NSC2020-01-21
00015482272838Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 100'sARKRAY USA, INC.NSC2020-01-21
00015482273538Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 10'sARKRAY USA, INC.NSC2020-01-21
00015482273835Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10'sARKRAY USA, INC.NSC2020-01-21
00300520311540FOLLISTIM PEN STARTER KIT USAMerck Sharp & Dohme LLCNSC2019-11-14
60300520311542FOLLISTIM PEN STARTER KIT USAMERCK SHARP & DOHME CORP.NSC2019-11-14
00300520311533FOLLISTIM PEN STARTER KIT SAM USAMerck Sharp & Dohme LLCNSC2019-10-28
60300520311535FOLLISTIM PEN STARTER KIT SAM USAMERCK SHARP & DOHME CORP.NSC2019-10-28
00355513192019Onpro kitAMGEN INC.NSC2019-09-24
00358406470010AutoTouch reusable autoinjectorAMGEN INC.NSC2019-09-24
10358406470017AutoTouch reusable autoinjectorAMGEN INC.NSC2019-09-24
10300132647034Genotropin Pen® 12PHARMACIA & UPJOHN COMPANY LLCNSC2019-09-05
10300134761929Genotropin Pen® 5PHARMACIA & UPJOHN COMPANY LLCNSC2019-09-05