Home GUDID 00860001977356 Onset
Primary DI 00860001977356
Brand Onset
Company Onpharma Company
Model 41938-03
Device description Onset EZ™ Buffering Pen, 2.8-3.0mL volume, single pack
Published 2025-09-19
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
Sterile true Product Codes# Code, Name table Code Name NEP System/Device, Pharmacy Compounding
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NEP System/Device, Pharmacy Compounding General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860001977356 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 00860001977356 00860001977356 860001977356 0860001977356
GMDN Terms# Term, Definition table Term Definition Fluid transfer set, general-purpose A collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 081037594 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00887709166288 ICU Medical, Inc. ICU MEDICAL, INC. NEP 2026-04-16 00887709166295 ICU Medical, Inc. ICU MEDICAL, INC. NEP 2026-04-16 00887709166318 ICU Medical, Inc. ICU MEDICAL, INC. NEP 2026-04-16 00887709170988 ICU Medical, Inc. ICU MEDICAL, INC. NEP 2026-04-16 00887709127371 ICU Medical, Inc. ICU MEDICAL, INC. NEP 2026-04-01 00887709127388 ICU Medical, Inc. ICU MEDICAL, INC. NEP 2026-04-01 00887709127395 ICU Medical, Inc. ICU MEDICAL, INC. NEP 2026-04-01 00887709127432 ICU Medical, Inc ICU MEDICAL, INC. NEP 2026-04-01 00887709125995 ICU Medical, Inc. ICU MEDICAL, INC. NEP 2026-01-12 00887709167216 ICU Medical, Inc. ICU MEDICAL, INC. NEP 2025-10-20 00085412169286 DUO-VENT Baxter Healthcare SA NEP 2025-03-20 50085412169281 DUO-VENT Baxter Healthcare SA NEP 2025-03-20 00860006285043 IVX Manager Omnicell, Inc. NEP 2024-05-10 00840619054908 DianaTM Automated Drug Compounding System ICU MEDICAL, INC. NEP 2024-02-20 00840619065058 DianaTM Automated Drug Compounding System ICU MEDICAL, INC. NEP 2024-02-20 00840619089894 DianaTM Automated Drug Compounding System ICU MEDICAL, INC. NEP 2024-02-20 00840619090876 DianaTM Automated Drug Compounding System ICU MEDICAL, INC. NEP 2024-02-20 00840619091590 DianaTM Automated Drug Compounding System ICU MEDICAL, INC. NEP 2024-02-20 00850033629408 Acta Medical Acta Medical LLC NEP 2024-02-14 00860006285036 IVX Cloud Omnicell, Inc. NEP 2024-01-10 08426314948258 GRI-FILL LABORATORIOS GRIFOLS SA NEP 2023-07-19 00887709125117 DianaTM Compounding Workflow System ICU MEDICAL, INC. NEP 2023-04-10 00887709125124 DianaTM Compounding Workflow System ICU MEDICAL, INC. NEP 2023-04-10 00887709125131 DianaTM Compounding Workflow System ICU MEDICAL, INC. NEP 2023-04-10 00887709125735 DianaTM Compounding Workflow System ICU MEDICAL, INC. NEP 2023-04-10 00887709126497 DianaTM Compounding Workflow System ICU MEDICAL, INC. NEP 2023-04-10 00887709126589 DianaTM Compounding Workflow System ICU MEDICAL, INC. NEP 2023-04-10 00887709126596 DianaTM Compounding Workflow System ICU MEDICAL, INC. NEP 2023-04-10 00887709126749 DianaTM Compounding Workflow System ICU MEDICAL, INC. NEP 2023-04-10 00887709126770 DianaTM Compounding Workflow System ICU MEDICAL, INC. NEP 2023-04-10
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