FDA.reportPublic FDA data

Administration Set

Primary DI
30301697200065
Brand
Administration Set
Company
NOVO NORDISK INC.
Model
720006
Catalog number
720006
Device description
Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, and 2 bandages.
Published
2017-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRSI.V. Start Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30301697200065PackageGS148In Commercial Distribution
00301697200064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030169720006530301697200065
00301697200064003016972000643016972000640301697200064

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous medicine administration kit, non-medicated, single-useA collection of sterile devices intended to be used to administer various types of medication (non-dedicated) by injection. It will typically contain a syringe, a needle, extension tubing, adaptors, and antiseptic applicator, but not the medication. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store at extreme temperatures and humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-727-6500nnicustomercare@novonordisk.com
+18007276500nnicustomercare@novonordisk.com

Regulatory Flags#

DUNS number
012177531
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00301691851897NovoFine® 32G Tip1851891851892016-09-17
00301691851972NovoFine® 32G Tip1851971851972016-09-17
00301691852757NovoFine® Autocover® 30G1852751852752016-09-17
00301691854591NovoPen Echo®1854591854592016-11-23
00301691855505NovoFine® Plus 32G1855501855502016-09-17
00301691855918NovoFine® Plus 32G1855911855912016-09-17
00301691856502NovoFine® Plus 32G1856501856502017-12-06
00301691856519NovoFine® Plus 32G1856511856512017-12-06
00301691858506NovoFine® Plus 32G1858501858502017-12-06
00301691858513NovoFine® Plus 32G1858511858512017-12-06
00301697200064Administration Set7200067200062017-06-13
00301697712901FlexPro® PenMate®7712907712902019-08-08
00301691852979NovoFine® Autocover® 30G1852971852972016-09-17
00301691852504NovoFine® 30G1852501852502016-09-17
30301691851898NovoFine® 32G Tip1851891851892016-09-17
30301691851973NovoFine® 32G Tip1851971851972016-09-17
30301691854592NovoPen Echo®1854591854592016-11-23
00301691853891NovoTwist® 32G1853891853892016-09-17
30301691852758NovoFine® Autocover® 30G1852751852752016-09-17
30301691852970NovoFine® Autocover® 30G1852971852972016-09-17

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Primary DI, Brand, Company table
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