FDA.reportPublic FDA data

FOLLISTIM PEN STARTER KIT SAM

Primary DI
60840164519459
Brand
FOLLISTIM PEN STARTER KIT SAM
Company
Organon LLC
Model
1044943
Published
2024-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSCINJECTOR, PEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSCInjector, PenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60840164519459PackageGS112In Commercial Distribution
00840164519457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6084016451945960840164519459
00840164519457008401645194578401645194570840164519457

GMDN Terms#

Term, Definition table
TermDefinition
Cartridge-accepting autoinjector, 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 to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and typically a dial on the device is operated for dosing (e.g., via a spring-loaded mechanism); the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.25Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117494753
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00840164521139JADA SystemJADA-20022023-02-15
60840164521131JADA SystemJADA-20022023-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840164519440FOLLISTIM PEN STARTER KITOrganon LLCNSC2024-01-01
00840164519457FOLLISTIM PEN STARTER KIT SAMOrganon LLCNSC2024-01-01
60840164519442FOLLISTIM PEN STARTER KITOrganon 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