AccessGUDID - DEVICE: easypod (04054839025860)

GUDID

Device Identifier (DI) Information

Brand Name: easypod
Version or Model: U1222102
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EMD SERONO, INC.

Primary DI Number: 04054839025860
Issuing Agency: GS1
Commercial Distribution End Date: October 18, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 088514898 *Terms of Use

Device Description: easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]) in cartridges.

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?
45819	Empty self-injector, electronic	A portable, hand-held, battery-powered device 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. The device includes an electronic display and may be capable of a variety of dose-recording functions. The needle is replaced for each administration. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: f2f61da2-e974-44f3-a071-745c07c68b40
Public Version Date: April 03, 2024
Public Version Number: 3
DI Record Publish Date: April 11, 2019