novonordisk.comNovoFine
Novo Nordisk Inc.
NOVO NORDISK INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2244771 | 2244771 | NOVO NORDISK INC. | 1 | Y | 2026-01-01 | 800 Scudders Mill Rd Plainsboro NJ US 08536 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00301691851897 | NovoFine® 32G Tip - NovoFine® 32G Tip is a sterile disposable needle. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691851972 | NovoFine® 32G Tip - NovoFine® 32G Tip is a sterile disposable needle. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691852757 | NovoFine® Autocover® 30G - NovoFine® Autocover® is a sterile, non-toxic, non-pyrogenic, single use injection needle designed and recommended for use with Novo Nordisk® insulin delivery devices. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691854591 | NovoPen Echo® - NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691855505 | NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691863012 | NOVOFINE PLUS 29G - NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691863500 | NOVOFINE PLUS 29G - NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691863906 | NovoFine® Plus 29G - NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device. | +18007276500 | nnicustomercare@novonordisk.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 16570 | 1698140132 | K231255 | NovoFine® Plus | FMI | 2023-08-25 |
| 16570 | 1423395103 | K210258 | NovoFine | FMI | 2021-06-23 |
| 16570 | 1382197461 | K202005 | NovoFine Plus 32G Tip x 4 mm | FMI | 2020-12-19 |
| 16570 | 2008167522 | K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | 2018-12-17 |
| 16570 | 1745006875 | K173479 | NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) | FMI | 2018-01-17 |
| 16570 | 1643284362 | K162602 | NovoPen Echo | FMF | 2016-10-18 |
| 16570 | 1189984943 | K133738 | NOVOFINE PLUS 32G 4 MM | FMI | 2014-05-21 |
| 16570 | 1051318870 | K093109 | NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') | FMI | 2010-06-18 |
| 16570 | 1016246524 | K090111 | FLEXPEN NEEDLE | FMI | 2010-02-01 |
| 16570 | 1080572543 | K050106 | NOVOFINE AUTOCOVER 30G X 8MM | FMI | 2005-03-30 |
| 16570 | 1012223184 | ||||
| 16570 | 1610738297 | ||||
| 16570 | 1844645649 |
Product Codes Associated With Registrations#
PMN#
NovoFine Plus 32G Tip X 4 Mm
Novo Nordisk Inc.
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
Novo Nordisk Inc.
NovoFine 32G Tip (0.23/0.25) X 6 Mm ETW (extra Thin Wall)
Novo Nordisk Inc.
NovoPen Echo
Novo Nordisk Inc.
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
NOVO NORDISK INC.
NOVOFINE PLUS 32G 4 MM
NOVO NORDISK INC.
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
NOVO NORDISK INC.
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
NOVO NORDISK INC.
FLEXPEN NEEDLE
NOVO NORDISK INC.
FLEXPEN NEEDLE
NOVO NORDISK INC.
NOVOFINE 32G TIP
NOVO NORDISK INC.
NOVOFINE AUTOCOVER 30G X 8MM
NOVO NORDISK INC.
GUDID#
NOVOFINE PLUS 29G - NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device.
2026-07-31
NOVOFINE PLUS 29G - NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device.
2026-07-31
NovoFine® Plus 29G - NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device.
2026-07-31
NovoFine® 32G Tip - NovoFine® 32G Tip is a sterile disposable needle.
2016-09-17
NovoFine® 32G Tip - NovoFine® 32G Tip is a sterile disposable needle.
2016-09-17
NovoFine® Autocover® 30G - NovoFine® Autocover® is a sterile, non-toxic, non-pyrogenic, single use injection needle designed and recommended for use with Novo Nordisk® insulin delivery devices.
2016-09-17
NovoPen Echo® - NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.
2016-11-23
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
2016-09-17
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
2016-09-17
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
2017-12-06
NovoFine® Plus 32G - 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.
2017-12-06
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
2017-12-06
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
2017-12-06
Administration Set - Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, and 2 bandages.
2017-06-13
FlexPro® PenMate® - Auto-insertion accessory only for Norditropin® FlexPro® 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL prefilled pens. Designed and intended for use with Novo Nordisk® disposable needles.
2019-08-08
NovoFine® Autocover® 30G - NovoFine® Autocover® is a sterile, non-toxic, non-pyrogenic, single use injection needle designed and recommended for use with Novo Nordisk® insulin delivery devices.
2016-09-17
NovoFine® 30G - 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.
2016-09-17
NovoFine® 32G Tip - NovoFine® 32G Tip is a sterile disposable needle.
2016-09-17
NovoFine® 32G Tip - NovoFine® 32G Tip is a sterile disposable needle.
2016-09-17
NovoPen Echo® - NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.
2016-11-23
NovoTwist® 32G - NovoTwist® 32G is a single use disposable injection needle intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.
2016-09-17
NovoFine® Autocover® 30G - NovoFine® Autocover® is a sterile, non-toxic, non-pyrogenic, single use injection needle designed and recommended for use with Novo Nordisk® insulin delivery devices.
2016-09-17
NovoFine® Autocover® 30G - NovoFine® Autocover® is a sterile, non-toxic, non-pyrogenic, single use injection needle designed and recommended for use with Novo Nordisk® insulin delivery devices.
2016-09-17
NovoTwist® 32G - NovoTwist® 32G is a single use disposable injection needle intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.
2016-09-17
NovoFine® Plus 32G - 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.
2016-09-17
NovoFine® Plus 32G - 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.
2016-09-17
NovoFine® Plus 32G - 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.
2017-12-06
NovoFine® Plus 32G - 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.
2017-12-06
NovoFine® Plus 32G - 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.
2017-12-06
NovoFine® Plus 32G - 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.
2017-12-06
NovoFine® 30G - 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.
2016-09-17
Administration Set - Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, and 2 bandages.
2017-06-13