AP204-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET

Primary DI
27290109153104
Brand
AP204-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET
Company
Q-CORE MEDICAL LTD
Model
12003-000-0070
Catalog number
12003-000-0070
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral 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
27290109153104PackageGS130In Commercial Distribution
17290109153107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729010915310427290109153104
1729010915310717290109153107

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949.288.5482customerservice@eitanmedical.com

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
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
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
27290109153968Integrated power supply 15072-000-001015072-000-00102022-05-15
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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