FDA.reportPublic FDA data

Soft-Release-O

Primary DI
07613117010409
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 insulin pump."
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Contacts#

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

Regulatory Flags#

DUNS number
481742760
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10885403533839BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533846BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
01081633602518WUSA6010NEOCHILD, LLCFPA2026-10-08
10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
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00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10