FDA.reportPublic FDA data

Orbit®Inserter

Primary DI
07613117022235
Brand
Orbit®Inserter
Company
Ypsomed AG
Model
700012060
Catalog number
700012060
Device description
Insertion Device for Ypsomed Infusion Sets
Published
2017-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
07613117022235PackageGS110In Commercial Distribution
07613117021979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613117022235076131170222357613117022235
07613117021979076131170219797613117021979

GMDN Terms#

Term, Definition table
TermDefinition
Insulin infusion cannula introducerA non-sterile, hand-held, mechanical device intended to aid introduction of a cannula/needle subcutaneously into fatty tissue for use with an insulin infusion pump. It typically consists of a small housing that chambers the cannula and a triggered release mechanism for automated insertion of the cannula/needle into tissues. It is intended for use in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41344244111info@ypsomed.com

Regulatory Flags#

DUNS number
481742760
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613117034764Penfine Classic Pen Needles7000229167000229162023-06-19
07613117034818Penfine Classic Pen Needles7000229177000229172023-06-19
07613117034849Penfine Classic Pen Needles7000229187000229182023-06-19
07613117034795Penfine Classic Pen Needles7000229167000229162023-06-19
07613117034825Penfine Classic Pen Needles7000229177000229172023-06-19
07613117034863Penfine Classic Pen Needles7000229187000229182023-06-19
07613117016814Orbit softO4291OBO4291OB2016-09-24
07613117032302Clickfine Pen Needles7000215427000215422022-08-25
07613117032326Clickfine Pen Needles7000215427000215422022-08-25
07613117026264Clickfine AutoProtect7000148957000148952022-04-27
07613117026196Clickfine AutoProtect7000148957000148952022-04-27
07613117031282Clickfine pen needles7000199277000199272021-11-01
07613117031299Clickfine pen needles7000199277000199272021-11-01
07613117017422Soft-Release-MicroS3051S30512020-09-15
07613117017446Soft-Release-MicroS3081S30812020-09-15
07613117017460Soft-Release-MicroS6051S60512020-09-15
07613117017484Soft-Release-MicroS6081S60812020-09-15
07613117017507Soft-Release-MicroS8051S80512020-09-15
07613117017521Soft-Release-MicroS8081S80812020-09-15
07613117017606Soft-Release-MicroS3051S30512020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05713495000138SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
57622436104114Glatopaject ®AEROPHARM GmbHKZH2025-08-19
47622436104100Glatopaject ®AEROPHARM GmbHKZH2025-08-19
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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
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00643169705920Sil-serter™MEDTRONIC MINIMED, INC.KZH2022-09-17
00643169768086Minimed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
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05713495000077Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
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