Integrated power supply

Primary DI
27290109153968
Brand
Integrated power supply
Company
Q-CORE MEDICAL LTD
Model
15072-000-0010
Catalog number
15072-000-0010
Published
2022-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MRZAccessories, Pump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192860000Sapphire Infusion Pump, Sapphire administration setsQ Core Medical , Ltd.2020-11-19FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109153964Direct MarkingGS10
27290109153968PackageGS120In Commercial Distribution
27290109154446PackageGS110In Commercial Distribution
17290109153961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109153964072901091539647290109153964
2729010915396827290109153968
2729010915444627290109154446
1729010915396117290109153961

GMDN Terms#

Term, Definition table
TermDefinition
Basic power supply, reusableA device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533108028
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
false
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 DIBrandModelCatalogPublished
27290109154071Multi-Pump Mounting System compatible with IPS- A15171-000-000515171-000-00052022-05-16
27290109153067AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA12005-000-00032022-05-15
27290109153081AP433-01- INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, FX ADMINISTRATION CA12000-000-004412000-000-00442022-05-15
27290109153098AP416-01- MICROBORE INFUSION SET WITH FEMALE LUER LOCK, FX ADMINISTRATIO12003-000-001212003-000-00122022-05-15
27290109153104AP204-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET12003-000-007012003-000-00702022-05-15
27290109153128AP240-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET12003-000-006912003-000-00692022-05-15
27290109153135AP133-01- BLOOD SET WITH TWO NON-VENTED SPIKES, 2 ROLLER CLAMPS12006-000-001012006-000-00102022-05-15
27290109153159AP410-01- SECONDARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, ROLLER CLA12005-000-000712005-000-00072022-05-15
27290109153173AP504-01- UV RESISTANT INFUSION SET WITH VENTED / NON-VENTED DRIP CHAMBER, ROLLE12000-000-004512000-000-00452022-05-15
27290109153180AP213-01-MICROBORE INFUSION SET WITH NON-VENTED SPIKE, SLIDE CLAMP, ADMINISTRATI12003-000-001112003-000-00112022-05-15
27290109153197AP411-01- MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE, SLIDE CLAMP, NEED12003-000-007812003-000-00782022-05-15
27290109153203AP417-01- MICROBORE YELLOW MARKED INFUSION SET WITH NON-VENTED SPIKE AND NEURAXI12004-000-002212004-000-00222022-05-15
27290109153883Sapphire power supply-US (interchangeble heads)15072-000-000815072-000-00082022-05-15
27290109153890Splitter - US 15043-000-000515043-000-00052022-05-15
27290109153913Sapphire Multi-Pump Mounting System Power Supply – US17000-020-000817000-020-00082022-05-15
27290109153944PCA Lockbox 250mL15063-000-000115063-000-00012022-05-15
27290109153951PCA Lockbox 100 ml 15061-131-000415061-131-00042022-05-15
27290109153975Bolus handle - US15071-000-000515071-000-00052022-05-15
27290109153999Sapphire External Battery Pack15079-111-00012022-05-15
27290109154026Mini Cradle with Splitter - US17000-026-000717000-026-00072022-05-15

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