AccessGUDID - DEVICE: Genotropin Mixer® (10300130923796)

GUDID

Device Identifier (DI) Information

Brand Name: Genotropin Mixer®
Version or Model: F000092379
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PFIZER INC.

Primary DI Number: 10300130923796
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829076566 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46091	Basic growth hormone autoinjector, replaceable-cartridge	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 529a174f-25fa-4e9e-a112-00bfb67b0c14
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 01, 2016