FDA.reportPublic FDA data

FOLLISTIM PEN STARTER KIT SAM USA

Primary DI
00300520311533
Brand
FOLLISTIM PEN STARTER KIT SAM USA
Company
Merck Sharp & Dohme LLC
Model
1746811
Published
2019-10-28
Public version status
Update
Distribution status
Not 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
NSCINJECTOR, PEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSCInjector, PenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60300520311535PackageGS112Not in Commercial Distribution
00300520311533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6030052031153560300520311535
00300520311533003005203115333005203115330300520311533

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
Device Size Text, specify0
Device Size Text, specify0
Length6.25Inch
Needle Gauge29Gauge

Contacts#

Phone, Email table
PhoneEmail
+1(800)672-6372dpoc.usa@merck.com

Regulatory Flags#

DUNS number
101740835
Device count
1
DM exempt
true
Premarket exempt
true
Kit
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
00300520311540FOLLISTIM PEN STARTER KIT USA10226922019-11-14
00300520313018FOLLISTIM AQ Cartridge 300IU10226772019-11-14
00300520313810FOLLISTIM AQ Cartridge 300IU SAMPLE17468152019-10-28
00300520316019FOLLISTIM AQ Cartridge 600IU10226782019-11-14
00300520316811FOLLISTIM AQ Cartridge 600IU SAMPLE17468142019-10-28
00300520326018FOLLISTIM AQ Cartridge 900IU10226792019-11-14
00300858999991BCG Vaccine (Multiple Puncture Device)10399222023-04-10

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
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
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