FDA.report

sub Q infusion set

Primary DI
05705244004672
Brand
sub Q infusion set
Company
Unomedical A/S
Model
71-060-2738
Device description
Single use infusion set for subcutaneous infusion. The infusion set 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
FPASet, Administration, Intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05705244004689PackageGS1200In Commercial Distribution
05705244004672PrimaryGS10
05705244009868Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05705244004689057052440046895705244004689
05705244004672057052440046725705244004672
05705244009868057052440098685705244009868

GMDN Terms

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

TypeValueUnit
Angle90degree
Depth8Millimeter
Length60Centimeter

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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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
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