AccessGUDID - DEVICE: one.click (04054839025792)

GUDID

Device Identifier (DI) Information

Brand Name: one.click
Version or Model: U1222402
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EMD Serono, Inc.

Primary DI Number: 04054839025792
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: one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA 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?
45771	Empty self-injector, mechanical	A 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.	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: 9dda5114-2ec5-47be-8b2f-71323e2f58be
Public Version Date: September 11, 2024
Public Version Number: 4
DI Record Publish Date: April 11, 2019