FDA.report

Quick-set® Paradigm®

Primary DI
05705244006676
Brand
Quick-set® Paradigm®
Company
Unomedical A/S
Model
MMT-398600
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

Contact Domains

Product Codes

CodeName
FPASet, Administration, Intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05705244006683PackageGS1100In Commercial Distribution
05705244006676PrimaryGS10
05705244011823Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05705244006683057052440066835705244006683
05705244006676057052440066765705244006676
05705244011823057052440118235705244011823

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
Depth6Millimeter
Length110Centimeter

Storage And Handling

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

Sterilization Methods

Method

Contacts

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
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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