K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
Terumo Europe N.V.
TERUMO EUROPE N.V.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9681413 | 3001570557 | TERUMO EUROPE N.V. | 1 | N | 2027-01-01 | INTERLEUVENLAAN 40 LEUVEN Vlaams Brabant BE 3001 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 122474 | 1164273969 | K984576 | K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K | FMI | 1999-06-14 |
| 122474 | 1491173437 | K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | FMI | 2025-07-08 |
| 122474 | 1301650657 | K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | FMI | 2025-04-04 |
| 122474 | 1956631707 | K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | FMI | 2025-05-29 |
| 122474 | 1876607111 | K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | QYM | 2023-10-18 |
| 122474 | 1686730407 | K212095 | SurGuard3 Safety Hypodermic Needle | FMI | 2022-08-22 |
| 122474 | 1968850549 | K192057 | K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall | FMI | 2019-10-11 |
| 122474 | 2067070859 | K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH | FMF | 2017-02-10 |
| 122474 | 1676043412 | K152362 | Terumo SurGuard 3 Safety Hypodermic Needle | FMI | 2015-10-16 |
| 122474 | 1206760858 | K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall | FMI | 2015-06-25 |
| 122474 | 1969075110 | K150263 | K-Pack II Needle-21G x 2 | FMI | 2015-04-01 |
| 122474 | 1712144220 | K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) | FPA | 2014-03-18 |
| 122474 | 1750502050 | K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | FPA | 2014-02-05 |
| 122474 | 2020623443 | K132233 | K-PACK II NEEDLE - 27G X 3/4 THIN WALL | FMI | 2013-09-06 |
| 122474 | 1395048330 | K130520 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR | DTZ | 2013-03-13 |
| 122474 | 1230356597 | K122249 | TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE | FMI | 2012-08-28 |
| 122474 | 1728475147 | K113422 | TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE | FMI | 2012-03-05 |
| 122474 | 1983876283 | K111797 | 27 G X 1/2 K-PACK SURSHIELD NEEDLE | FMI | 2011-09-22 |
| 122474 | 1904682070 | K110850 | K-PACK II NEEDLE- 27G & 30G THIN WALL | FMI | 2011-06-09 |
| 122474 | 1845967739 | K110527 | K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE | FMI | 2011-06-06 |
| 122474 | 1053178809 | K100946 | INTRAVSCULAR ADMINISTRATION SET | FPA | 2010-08-02 |
| 122474 | 1204982085 | K082820 | K-PACK II NEEDLE - 29G THIN WALL | FMI | 2008-10-23 |
| 122474 | 1258451514 | K071494 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER | DTZ | 2007-07-16 |
| 122474 | 1367601842 | K070547 | SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD) | FPA | 2007-05-25 |
| 122474 | 1324783189 | K062608 | 29G AND 30G K-PACK II NEEDLE | FMI | 2006-09-15 |
| 122474 | 1567692711 | K051865 | TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR | MEG | 2005-09-27 |
| 122474 | 1513025386 | K023271 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | FMF | 2002-12-18 |
| 122474 | 1851473591 |
Product Codes Associated With Registrations#
PMN#
Terumo Injection Filter Needle (NF-3013RBKE05M)
Terumo Europe N.V.
SurGuard3 Safety Hypodermic Needle
Terumo Europe N.V.
K-Pack II Needle - 27G X 1/2” Extra Thin Wall, K-Pack II Needle - 27G X 1/2” Ultra Thin Wall, K-Pack II Needle - 30G X 1/2” Extra Thin Wall, K-Pack II Needle - 30G X 1/2” Ultra Thin Wall
Terumo Europe N.V.
Syringe With Fixed Needle - For Use Only With GONAL-F Multi-Dose 600 I/U ML FSH
TERUMO EUROPE N.V.
K-Pack II Needle - 29G X 5/16 Thin Wall
TERUMO EUROPE N.V.
K-Pack II Needle-21G X 2
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
TERUMO EUROPE N.V.
K-PACK II NEEDLE - 27G X 3/4 THIN WALL
TERUMO EUROPE N.V.
27 G X 1/2 K-PACK SURSHIELD NEEDLE
TERUMO EUROPE N.V.
K-PACK II NEEDLE- 27G & 30G THIN WALL
TERUMO EUROPE N.V.
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE
TERUMO EUROPE N.V.
INTRAVSCULAR ADMINISTRATION SET
TERUMO EUROPE N.V.
TERUMO SYRINGE WITH/WITHOUT NEEDLE
Terumo Europe N.V.
K-PACK II NEEDLE - 29G THIN WALL
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
TERUMO EUROPE N.V.
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET
TERUMO EUROPE N.V.
29G AND 30G K-PACK II NEEDLE
TERUMO EUROPE N.V.
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
TERUMO EUROPE N.V.
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS
TERUMO EUROPE N.V.
VENOJECT LUER ADAPTER
TERUMO EUROPE N.V.
NEOLUS NEEDLE
TERUMO EUROPE N.V.
K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K
TERUMO EUROPE N.V.