FDA.reportPublic FDA data

NovoFine® 30G

Primary DI
30301691852505
Brand
NovoFine® 30G
Company
NOVO NORDISK INC.
Model
185250
Catalog number
185250
Device description
NovoFine® 30G is a sterile, nontoxic, non-pyrogenic, single use injection needle designed and recommended for use with FlexPen® and all other Novo Nordisk® insulin delivery devices.
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30301691852505PackageGS160In Commercial Distribution
00301691852504PrimaryGS10
05712249050016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030169185250530301691852505
00301691852504003016918525043016918525040301691852504
05712249050016057122490500165712249050016

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Millimeter
Needle Gauge30Gauge

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
012177531
Device count
100
DM exempt
false
Premarket exempt
true
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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592468WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592475WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592499WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592505WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592512WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592529WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592536WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592543WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592550WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592567WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592598WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08