FDA.reportPublic FDA data

i-port ADVANCE™

Primary DI
05705244009370
Brand
i-port ADVANCE™
Company
Unomedical A/S
Model
MMT-101T
Device description
Single use injection port for subcutaneous injection. The injection port must be used as described in the Instruction for Use.
Published
2016-09-15
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
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05705244009387PackageGS1120In Commercial Distribution
05705244009370PrimaryGS10
05705244013322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05705244009387057052440093875705244009387
05705244009370057052440093705705244009370
05705244013322057052440133225705244013322

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous injection/infusion port needleA sterile, sharp bevel-edged, hollow tubular metal instrument attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle90degree
Depth9Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Do not store or leave the device in direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
306032491
Device count
2
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
false
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
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
05705244027107iLet FlexFG000063-052025-12-14
05705244027138iLet FlexFG000063-072025-12-14
05705244027152iLet FlexFG000063-092025-12-14
05705244027183iLet FlexFG000063-112025-12-14
05705244026322Inset II10143212025-11-06
05705244026346Inset II10143222025-11-06
05705244026261inset™FG000016-05n/a2024-05-02
05705244026292inset™FG000016-06n/a2024-05-02
05705244025271contact detachFG000016-032022-12-21
05705244025998Autosoft™ XC1010899N/A2023-06-13
05705244026025Autosoft™ XC10109002023-06-13
05705244026056Autosoft™ XC1009566N/A2023-06-13

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