FDA.reportPublic FDA data

MiniMed™ Duo™ Infusion Tubing

Primary DI
05705244005235
Brand
MiniMed™ Duo™ Infusion Tubing
Company
Unomedical A/S
Model
5082076-002
Device description
Single use infusion tubing for subcutaneous infusion. The infusion tubing must be used as described in the Instruction for Use.
Published
2016-09-15
Public version status
Update
Distribution status
Not 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
FPKTubing, Fluid Delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPKTubing, Fluid DeliveryGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002138000PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380Maersk Medical A/S2000-08-29FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05705244005242PackageGS1200In Commercial Distribution
05705244005235PrimaryGS10
05705244009790Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05705244005242057052440052425705244005242
05705244005235057052440052355705244005235
05705244009790057052440097905705244009790

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
Length60Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-646-4633xx@xx.xx

Regulatory Flags#

DUNS number
306032491
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05705244027176iLet FlexFG000063-092025-12-14
05705244026872iLet FlexFG000063-022025-12-14
05705244026902iLet FlexFG000063-042025-12-14
05705244026933iLet FlexFG000063-062025-12-14
05705244026964iLet FlexFG000063-082025-12-14
05705244026995iLet FlexFG000063-102025-12-14
05705244027022iLet FlexFG000063-122025-12-14
05705244027053iLet FlexFG000063-012025-12-14
05705244027084iLet FlexFG000063-032025-12-14
05705244027114iLet FlexFG000063-052025-12-14
05705244027145iLet FlexFG000063-072025-12-14
05705244027206iLet FlexFG000063-112025-12-14
05705244026865iLet FlexFG000063-022025-12-14
05705244026889iLet FlexFG000063-042025-12-14
05705244026926iLet FlexFG000063-062025-12-14
05705244026957iLet FlexFG000063-082025-12-14
05705244026988iLet FlexFG000063-102025-12-14
05705244027015iLet FlexFG000063-122025-12-14
05705244027046iLet FlexFG000063-012025-12-14
05705244027060iLet FlexFG000063-032025-12-14

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Primary DI, Brand, Company table
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10192253003352MonojectCardinal Health 200, LLCFPK2024-08-21
00616258024554Swabbable Valve Transfer SetBayer Medical Care Inc.FPK2024-05-06
00616258024561MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
00616258024820MEDRAD® Twist & Go Disposable Syringe 150mL with Quick Fill TubeBayer Medical Care Inc.FPK2024-05-06
10884450325312Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.FPK2021-04-05
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