Home GUDID 27290109154262 Sapphire M.T Infusion Pump Kit – US
Primary DI 27290109154262
Brand Sapphire M.T Infusion Pump Kit – US
Company Q-CORE MEDICAL LTD
Model 17000-028-0072
Catalog number 17000-028-0072
Published 2022-05-11
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FRN Pump, Infusion
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FRN Pump, Infusion General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290109154268 Direct Marking GS1 0 27290109154262 Package GS1 8 In Commercial Distribution 17290109154265 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290109154268 07290109154268 7290109154268 27290109154262 27290109154262 17290109154265 17290109154265
GMDN Terms# Term, Definition table Term Definition General-purpose infusion pump, line-powered A mains electricity (AC-powered) device designed to facilitate the accurate and consistent administration of drugs and solutions which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set. It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers. The device has a typical flow range of 1 to 999 ml/hour and delivers solutions from a standard infusion bag or bottle of fluid. It typically has internal batteries that enable operation for a short period when no mains electricity is available (e.g., during transportation or a power outage).
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -40 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 533108028 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false 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 27290109154071 Multi-Pump Mounting System compatible with IPS- A 15171-000-0005 15171-000-0005 2022-05-16 27290109153067 AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA 12005-000-0003 2022-05-15 27290109153081 AP433-01- INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, FX ADMINISTRATION CA 12000-000-0044 12000-000-0044 2022-05-15 27290109153098 AP416-01- MICROBORE INFUSION SET WITH FEMALE LUER LOCK, FX ADMINISTRATIO 12003-000-0012 12003-000-0012 2022-05-15 27290109153104 AP204-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET 12003-000-0070 12003-000-0070 2022-05-15 27290109153128 AP240-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET 12003-000-0069 12003-000-0069 2022-05-15 27290109153135 AP133-01- BLOOD SET WITH TWO NON-VENTED SPIKES, 2 ROLLER CLAMPS 12006-000-0010 12006-000-0010 2022-05-15 27290109153159 AP410-01- SECONDARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, ROLLER CLA 12005-000-0007 12005-000-0007 2022-05-15 27290109153173 AP504-01- UV RESISTANT INFUSION SET WITH VENTED / NON-VENTED DRIP CHAMBER, ROLLE 12000-000-0045 12000-000-0045 2022-05-15 27290109153180 AP213-01-MICROBORE INFUSION SET WITH NON-VENTED SPIKE, SLIDE CLAMP, ADMINISTRATI 12003-000-0011 12003-000-0011 2022-05-15 27290109153197 AP411-01- MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE, SLIDE CLAMP, NEED 12003-000-0078 12003-000-0078 2022-05-15 27290109153203 AP417-01- MICROBORE YELLOW MARKED INFUSION SET WITH NON-VENTED SPIKE AND NEURAXI 12004-000-0022 12004-000-0022 2022-05-15 27290109153883 Sapphire power supply-US (interchangeble heads) 15072-000-0008 15072-000-0008 2022-05-15 27290109153890 Splitter - US 15043-000-0005 15043-000-0005 2022-05-15 27290109153913 Sapphire Multi-Pump Mounting System Power Supply – US 17000-020-0008 17000-020-0008 2022-05-15 27290109153944 PCA Lockbox 250mL 15063-000-0001 15063-000-0001 2022-05-15 27290109153951 PCA Lockbox 100 ml 15061-131-0004 15061-131-0004 2022-05-15 27290109153968 Integrated power supply 15072-000-0010 15072-000-0010 2022-05-15 27290109153975 Bolus handle - US 15071-000-0005 15071-000-0005 2022-05-15 27290109153999 Sapphire External Battery Pack 15079-111-0001 2022-05-15
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08500835120017 Avoset Optum Homecare Infusion Optum Distribution Center, LLC FRN 2026-02-24 17290109155309 Sapphire M.T. Pump Kit C EITAN MEDICAL LTD FRN 2024-09-04 30815112021345 Elution Test Vial Bracco Diagnostics Inc. FRN 2024-02-13 10815112021396 CardioGen-82 Infusion System Model 1700 Bracco Diagnostics Inc. FRN 2023-12-01 10815112021358 CardioGen Patient Administration Set Bracco Diagnostics Inc. FRN 2023-10-16 17290109155149 Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTD FRN 2023-09-05 30815112021338 Accessory Package Bracco Diagnostics Inc. FRN 2023-06-29 30815112020034 Accessory Package Bracco Diagnostics Inc. FRN 2023-03-22 30815112020614 Accessory Package Bracco Diagnostics Inc. FRN 2023-03-22 17290109154272 Sapphire Epidural Infusion Pump Kit – US EITAN MEDICAL LTD FRN 2022-05-15 17290109154289 Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTD FRN 2022-05-15 17290109154265 Sapphire M.T Infusion Pump Kit – US EITAN MEDICAL LTD FRN 2022-05-11 10814844000365 Curlin IV Pump System ZEVEX INTERNATIONAL, INC. FRN 2021-04-29 15019517177367 PharmGuard ICU MEDICAL, INC. FRN 2020-03-20 15019517177374 PharmGuard ICU MEDICAL, INC. FRN 2020-03-20 10884521064843 Kangaroo Cardinal Health, Inc. FRN 2019-12-30 15019517155143 MEDFUSION ICU MEDICAL, INC. FRN 2019-09-20 15019517155150 MEDFUSION ICU MEDICAL, INC. FRN 2019-09-20 15019517155167 MEDFUSION ICU MEDICAL, INC. FRN 2019-09-20 15019517178067 Medfusion ICU MEDICAL, INC. FRN 2019-09-18 20763000273334 MiniMed™ Reservoir MEDTRONIC MINIMED, INC. FRN 2019-09-02 20763000273358 MiniMed™ Reservoir MEDTRONIC MINIMED, INC. FRN 2019-09-02 M33513852011 Plum 360 ICU MEDICAL, INC. FRN 2019-02-15 70643169771481 MiniMed™ Reservoir MEDTRONIC MINIMED, INC. FRN 2018-05-31 08050616611635 APO-GO Syringe reservoir CANE' SPA FRN 2018-05-28 17290109150229 SapphirePlus Infusion Kit - US EITAN MEDICAL LTD FRN 2018-02-22 09350902001614 Flow Control Tubing GO MEDICAL INDUSTRIES PTY. LTD. FRN 2017-05-18 09350902001690 Flow Control Tubing GO MEDICAL INDUSTRIES PTY. LTD. FRN 2017-05-18 09350902001720 Flow Control Tubing GO MEDICAL INDUSTRIES PTY. LTD. FRN 2017-05-18 09350902001751 Flow Control Tubing GO MEDICAL INDUSTRIES PTY. LTD. FRN 2017-05-18
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