DEVICE: NovoFine® Plus 32G (00301691855505)

Device Identifier (DI) Information

NovoFine® Plus 32G
185550
In Commercial Distribution
185550
NOVO NORDISK INC.
00301691855505
GS1

100
012177531 *Terms of Use
NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Autoinjector needle A 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FMI Needle, Hypodermic, Single Lumen
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K133738 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 4 Millimeter
Needle Gauge: 32 Gauge
CLOSE

Device Record Status

680fd340-3034-4874-a52c-ff22af41d6c1
July 06, 2018
3
September 17, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30301691855506 60 00301691855505 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 05712249050122 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-727-6500
nnicustomercare@novonordisk.com
CLOSE