FDA.reportPublic FDA data

AutoTouch Connect reusable autoinjector

Primary DI
00358406480019
Brand
AutoTouch Connect reusable autoinjector
Company
AMGEN INC.
Model
9006940
Device description
AutoTouch Connect reusable autoinjector with optional Bluetooth wireless feature for use with Enbrel Mini (etanercept) single-dose prefilled cartridge
Published
2021-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
NSCInjector, Pen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSCInjector, PenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10358406480016PackageGS115In Commercial Distribution
00358406480019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1035840648001610358406480016
00358406480019003584064800193584064800190358406480019

GMDN Terms#

Term, Definition table
TermDefinition
Empty self-injector, 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 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not refrigerate
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Store at room temperature
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Regulatory Flags#

DUNS number
039976196
Device count
1
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00355513770019Repatha Pushtronex System90028702019-09-24
00355513770910Repatha Pushtronex System, sample90032432021-12-13
00372511770018Repatha Pushtronex System90066552021-12-13
00372511770919Repatha Pushtronex System, sample90081242022-08-24
00358406470010AutoTouch reusable autoinjector90036002019-09-24
10372511770916Repatha Pushtronex System, sample90081242022-08-24
00358406425911Enbrel 25 mg/vial Replacement6425912021-12-13
10355513770917Repatha Pushtronex System, sample90032432021-12-13
10358406425918Enbrel 25 mg/vial Replacement6425912021-12-13
10372511770015Repatha Pushtronex System90066552021-12-13
10358406480016AutoTouch Connect reusable autoinjector90069402021-11-08
00358406425348Enbrel 25 mg/vial Multiple-use Vial6425342019-10-24
10358406425345Enbrel 25 mg/vial Multiple-use Vial6425342019-10-24
00355513192019Onpro kit90021362019-09-24
10355513192016Onpro kit90021362019-09-24
10355513770016Repatha Pushtronex System90028702019-09-24
10358406470017AutoTouch reusable autoinjector90036002019-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840164519440FOLLISTIM PEN STARTER KITOrganon LLCNSC2024-01-01
00840164519457FOLLISTIM PEN STARTER KIT SAMOrganon LLCNSC2024-01-01
60840164519442FOLLISTIM PEN STARTER KITOrganon LLCNSC2024-01-01
60840164519459FOLLISTIM PEN STARTER KIT SAMOrganon LLCNSC2024-01-01
57622436000010Omnitrope® Pen 10Sandoz Inc.NSC2023-10-05
57622436000027Omnitrope® Pen 5Sandoz Inc.NSC2023-10-05
57612799210546Omnitrope Pen 10Sandoz GmbHNSC2023-02-07
59002269207349Omnitrope Pen 5Sandoz GmbHNSC2023-02-07
47612799222856Omnitrope Pen 10Sandoz GmbHNSC2023-02-07
47612799222849Omnitrope Pen 5Sandoz GmbHNSC2023-02-07
49002269218553Omnitrope Pen 10Sandoz GmbHNSC2023-02-07
10358406480016AutoTouch Connect reusable autoinjectorAMGEN INC.NSC2021-11-08
00015482272531Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 100'sARKRAY USA, INC.NSC2020-01-21
00015482272838Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 100'sARKRAY USA, INC.NSC2020-01-21
00015482273538Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 10'sARKRAY USA, INC.NSC2020-01-21
00015482273835Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10'sARKRAY USA, INC.NSC2020-01-21
00300520311540FOLLISTIM PEN STARTER KIT USAMerck Sharp & Dohme LLCNSC2019-11-14
60300520311542FOLLISTIM PEN STARTER KIT USAMERCK SHARP & DOHME CORP.NSC2019-11-14
00300520311533FOLLISTIM PEN STARTER KIT SAM USAMerck Sharp & Dohme LLCNSC2019-10-28
60300520311535FOLLISTIM PEN STARTER KIT SAM USAMERCK SHARP & DOHME CORP.NSC2019-10-28
00355513192019Onpro kitAMGEN INC.NSC2019-09-24
00358406470010AutoTouch reusable autoinjectorAMGEN INC.NSC2019-09-24
10358406470017AutoTouch reusable autoinjectorAMGEN INC.NSC2019-09-24
10300132647034Genotropin Pen® 12PHARMACIA & UPJOHN COMPANY LLCNSC2019-09-05
10300134761929Genotropin Pen® 5PHARMACIA & UPJOHN COMPANY LLCNSC2019-09-05