FDA.reportPublic FDA data

MiniMed Sure-T

Primary DI
05705244019423
Brand
MiniMed Sure-T
Company
Unomedical A/S
Model
MMT-884A
Device description
Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Published
2019-06-18
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
05705244019423PackageGS1200In Commercial Distribution
05705244019416PrimaryGS10
05705244019430Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05705244019423057052440194235705244019423
05705244019416057052440194165705244019416
05705244019430057052440194305705244019430

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
Angle90degree
Depth10Millimeter
Length60Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
306032491
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
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
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationFPA2026-06-30
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23