Skytrofa Auto-Injector

Primary DI
05713495000077
Brand
Skytrofa Auto-Injector
Company
Phillips-Medisize A/S
Model
1002247
Published
2021-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KZHIntroducer, Syringe Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZHIntroducer, Syringe NeedleGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713495000084PackageGS110In Commercial Distribution
05713495000077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713495000084057134950000845713495000084
05713495000077057134950000775713495000077

GMDN Terms#

Term, Definition table
TermDefinition
Empty self-injector, electronicA portable, hand-held, battery-powered device, commonly referred to as an electronic autoinjector, 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.

Regulatory Flags#

DUNS number
306047440
Device count
1
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713495001128VYAFUSER™VYAFUSER PUMP KIT US (R)20898704102025-09-03
05713495000121SKYTROFA Auto-Injector022025-08-20
05713495000138SKYTROFA Auto-Injector022025-08-20
05713495000152VYAFUSER™VYAFUSER PUMP KIT US/PR A20898704102024-11-13
05713495001043VYAFUSER™VYAFUSER PUMP KIT US/PR A20898704102024-11-13
05713495000053myBETAappiOS (Mobile App)846010632019-10-07
05713495000060myBETAappAndroid (Mobile App)846010632019-10-07
05713495000015BETACONNECT82289801822898012019-10-07
05713495000084Skytrofa Auto-Injector10022472021-10-22
05713495000039myBETAappWindows Thin Client (Desktop)846010632019-10-07
05713495000046myBETAappMac Thin Client (Desktop)846010632019-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B33919800010V-CathNeo Medical Inc.KZH2026-03-27
05713495000121SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
05713495000138SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
57622436104114Glatopaject ®AEROPHARM GmbHKZH2025-08-19
47622436104100Glatopaject ®AEROPHARM GmbHKZH2025-08-19
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncKZH2025-08-01
00850037806058Orbit InserterModular Medical, Inc.KZH2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.KZH2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.KZH2025-07-11
00370095000002GripMate™SUN PHARMACEUTICAL INDUSTRIES, INC.KZH2025-05-12
05714472000004Needle Guide AssistantUnion Medico ApSKZH2025-05-05
B33935290030NeoMagicNeo Medical Inc.KZH2025-01-22
B33935290035NeoMagicNEO MEDICAL INC.KZH2025-01-22
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00860006961534Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00817708022964AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00817708022988AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00643169705920Sil-serter™MEDTRONIC MINIMED, INC.KZH2022-09-17
00643169768086Minimed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
00763000573690MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
05713495000084Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
00763000381080Sil-serter™MEDTRONIC MINIMED, INC.KZH2021-04-22
00763000354817MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2020-06-14
05713495000015BETACONNECTPhillips-Medisize A/SKZH2019-10-07
00355513192019Onpro kitAMGEN INC.KZH2019-09-24
10355513192016Onpro kitAMGEN INC.KZH2019-09-24
00301697712901FlexPro® PenMate®NOVO NORDISK INC.KZH2019-08-08
00025294874007Inject-EaseAMBI, INC.KZH2018-12-17
57612799202398Extavia® Auto-Injector IINOVARTIS PHARMACEUTICALS CORPORATIONKZH2018-09-24
47612799202391Extavia® Auto-Injector IINOVARTIS PHARMACEUTICALS CORPORATIONKZH2018-09-24