FDA.reportPublic FDA data

FOLLISTIM AQ Cartridge 600IU

Primary DI
00300520316019
Brand
FOLLISTIM AQ Cartridge 600IU
Company
Merck Sharp & Dohme LLC
Model
1022678
Published
2019-11-14
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
FMINeedle, hypodermic, single lumen

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60300520316011PackageGS124Not in Commercial Distribution
00300520316019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6030052031601160300520316011
00300520316019003005203160193005203160190300520316019

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(800)672-6372dpoc.usa@merck.com

Regulatory Flags#

DUNS number
101740835
Device count
1
DM exempt
true
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
00300520311533FOLLISTIM PEN STARTER KIT SAM USA17468112019-10-28
00300520311540FOLLISTIM PEN STARTER KIT USA10226922019-11-14
00300520313018FOLLISTIM AQ Cartridge 300IU10226772019-11-14
00300520313810FOLLISTIM AQ Cartridge 300IU SAMPLE17468152019-10-28
00300520316811FOLLISTIM AQ Cartridge 600IU SAMPLE17468142019-10-28
00300520326018FOLLISTIM AQ Cartridge 900IU10226792019-11-14
00300858999991BCG Vaccine (Multiple Puncture Device)10399222023-04-10

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