Home GUDID 30382905156282
BD PhaSeal Optima
Primary DI 30382905156282
Brand BD PhaSeal Optima
Company BD Switzerland Sàrl
Model 515628
Catalog number 515628
Device description BD Phaseal™ Optima Spike Set (C180-O)
Published 2025-12-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name ONB Closed antineoplastic and hazardous drug reconstitution and transfer system
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30382905156282 Package GS1 50 In Commercial Distribution 50382905156286 Package GS1 4 In Commercial Distribution 00382905156281 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 30382905156282 30382905156282 50382905156286 50382905156286 00382905156281 00382905156281 382905156281 0382905156281
GMDN Terms# Term, Definition table Term Definition Non-ISO80369 formatted bag access spike A small, noninvasive, tubular connector with a small-bore connection/port, none of which is designed according to ISO 80369 (non-ISO80369 formatted), and a hollow bag-access spike (either blunt or sharp) intended to connect an intravenous (IV) fluid or blood bag to a fluid line for administration to a patient. It may include a built-in air filter and drip chamber; it does not include tubing (i.e., not a tubing set) or any Luer formatted connections. This is a single-use device.
Regulatory Flags# DUNS number 482631558 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 DI Brand Model Catalog Published 10885403237898 Tru-Secure TS1000 TS1000 2016-10-17 00382903949106 Connecta, Luer-Lok 394910 394910 2023-09-21 00382905156298 BD PhaSeal Optima 515629 515629 2026-01-09 30382905156299 BD PhaSeal Optima 515629 515629 2026-01-09 00382905156281 BD PhaSeal Optima 515628 515628 2025-12-19 10885403235610 Alaris C25012 C25012 2016-09-22 07613203010931 Alaris, SmartSite 42290E 42290E 2016-10-17 07613203010962 Alaris, SmartSite 42273E 42273E 2016-09-22 10885403222610 Alaris MS3500-15 MS3500-15 2016-09-22 10885403234859 Alaris, SmartSite 20027E 20027E 2016-09-22 10885403235306 Alaris, SmartSite 41177E 41177E 2016-09-22 10885403274220 Alaris, SmartSite 41176E 41176E 2016-09-22 10885403230110 Alaris 10016073 10016073 2016-09-22 07613203010917 Alaris, SmartSite 42293E 42293E 2016-09-22 10885403236532 BD MaxPlus MP2000 MP2000 2016-09-22 10885403236778 BD MaxPlus MP9004 MP9004 2016-09-22 10885403236990 BD MaxPlus MP9218-C MP9218-C 2016-09-22 10885403302060 Alaris, SmartSite MPC-02 MPC-02 2016-09-22 00382905150012 BD PhaSeal 515001 515001 2016-09-19 00382905150036 BD PhaSeal 515003 515003 2016-09-19
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