FDA.reportPublic FDA data

Genotropin Mixer®

Primary DI
10300130923796
Brand
Genotropin Mixer®
Company
PFIZER INC.
Model
F000092379
Device description
The Genotropin Mixer is a device used to mix growth hormone that is provided in a Two-Chamber Cartridge (TCC). The Genotropin Mixer is a non-sterile, reusable medical device designed for mixing the Genotropin TCC.
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10300130923796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1030013092379610300130923796

GMDN Terms#

Term, Definition table
TermDefinition
Basic growth hormone autoinjector, replaceable-cartridgeA portable hand-held device, typically in the form of a large pen, designed to be used by an adult or a child patient to subcutaneously inject a dose of human growth hormone through a replaceable needle. A replaceable cartridge filled with growth hormone medication is inserted into the device and typically a dial on the device is operated for dosing; only the cartridge is discarded when the growth hormone medication is exhausted. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(484)865-6166karena.arroyo@pfizer.com

Regulatory Flags#

DUNS number
829076566
Device count
1
DM exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true

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00305733010983ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733013014ThermaCare HeatWrapsThermaCare HeatWraps - Muscle & Joint2020-05-29
00305733013038ThermaCare HeatWrapsThermaCare HeatWraps - Muscle & Joint2020-05-29
00305733013144ThermaCare HeatWrapsThermaCare HeatWraps - Muscle & Joint2020-05-29
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00305733017241ThermaCare HeatWrapsThermaCare HeatWraps - Flexible2020-05-29
00305733017258ThermaCare HeatWrapsThermaCare HeatWraps - Flexible2020-05-29
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