FDA.report

i-port ADVANCE™

Primary DI
05705244014190
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
2017-03-31
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

Related Records

Contact Domains

Product Codes

CodeName
FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Product Code Classifications

CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05705244014190PackageGS1120In Commercial Distribution
05705244014183PrimaryGS10
05705244014206Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05705244014190057052440141905705244014190
05705244014183057052440141835705244014183
05705244014206057052440142065705244014206

GMDN Terms

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

TypeValueUnit
Angle90degree
Depth9Millimeter

Storage And Handling

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

Sterilization Methods

Method

Contacts

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

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