FDA.reportPublic FDA data

Soft-Release-O

Primary DI
07613117010416
Brand
Soft-Release-O
Company
Ypsomed AG
Model
S3091
Catalog number
S3091
Device description
Soft-Release-O Infusion Set, 9 mm soft cannula, 30 cm (12") blue tubing. / Infusion set with a soft cannula designed to work with the DANA DIABECARE i
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613117010416PackageGS110In Commercial Distribution
07613117010409PrimaryGS10
07613117017354Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613117010416076131170104167613117010416
07613117010409076131170104097613117010409
07613117017354076131170173547613117017354

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)747-6645support@sooilusa.com

Regulatory Flags#

DUNS number
481742760
Device count
10
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
true
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
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
00616784894027LabChoice SecureSafety Safety Blood Collection Sets, Sterile,Dynarex CorporationFPA2018-05-26
00616784894126LabChoice SecureSafety Safety Blood Collection Sets, SterileDynarex CorporationFPA2018-05-26