one.click

Primary DI
04054839025792
Brand
one.click
Company
EMD Serono, Inc.
Model
U1222402
Device description
one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in cartridges.
Published
2019-04-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054839025792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054839025792040548390257924054839025792

GMDN Terms#

Term, Definition table
TermDefinition
Cartridge-accepting autoinjector, mechanicalA 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 to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and typically a dial on the device is operated for dosing (e.g., via a spring-loaded mechanism); the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-447-3243xx@xx.xx

Regulatory Flags#

DUNS number
088514898
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964756290Pencylcap needleU1944111P14000632018-10-19
04054839025860easypodU12221022019-04-11
04046963413873Serofine needles 29 GU124411816441EMD2019-04-11
04046963414030Serofine needles 30GU124411916442EMD2019-04-11
04046963412791one.click needleU124410116440EMD2016-08-26
04054839025808Rebiject IIU67223022016-08-26
04054839025914Clip-on Spacers for RebifU67440042016-08-26
04046963413880Serofine needles 29 GU124411816441EMD2019-04-11
04046963414047Serofine needles 30GU124411916442EMD2019-04-11