FDA.report

insuflon™

Primary DI
05705244004030
Brand
insuflon™
Company
Unomedical A/S
Model
98-000-2612
Device description
Single use indwelling catheter for multiple subcutaneous injections. The indwelling catheter 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

Related Records

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
05705244004047PackageGS1200In Commercial Distribution
05705244004030PrimaryGS10
05705244013414Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05705244004047057052440040475705244004047
05705244004030057052440040305705244004030
05705244013414057052440134145705244013414

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
Angle30degree
Needle Gauge27Gauge

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from direct sunlight. Store at room temperature.

Sterilization Methods

Method

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
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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