FDA.reportPublic FDA data

Mini Cradle with Splitter- US

Primary DI
07290109150000
Brand
Mini Cradle with Splitter- US
Company
Q-CORE MEDICAL LTD
Model
17000-026-0007
Catalog number
17000-026-0007
Published
2016-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K123049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123049000SAPPHIRE INFUSION PUMPQ Core Medical , Ltd.2013-10-17FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109150000Direct MarkingGS10
27290109150011PackageGS120Not in Commercial Distribution
27290109150042PackageGS120In Commercial Distribution
27290109150110PackageGS120In Commercial Distribution
17290109150007PreviousGS10
17290109150014PreviousGS10
17290109150045PrimaryGS10
17290109150113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109150000072901091500007290109150000
2729010915001127290109150011
2729010915004227290109150042
2729010915011027290109150110
1729010915000717290109150007
1729010915001417290109150014
1729010915004517290109150045
1729010915011317290109150113

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous pole multi-outlet holderA mains electricity (AC-powered) device used with an intravenous (IV) pole (usually of the floor-standing type) and designed to provide multiple electrical outlet sockets so that an electrical source is made available when two or more infusion pumps are mounted into the retaining slots provided. This device will fit onto a standard IV pole and is intended to accept the mounting of a number of infusion pumps, keeping them safely fastened to the pole in an organized manner.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-241-4002sapphireGCM@icumed.com
1-800-241-4002sapsapphiregcm@pfe.icumed.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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B553202293OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
00085412718378Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
00085412947914Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
G001RG31RGChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.MRZ2025-06-27
00840365902096InvenioGri-Alleset, Inc.MRZ2025-03-12
10840365902093InvenioGRI Medical & Electronic Technology Co., Ltd.MRZ2025-03-12
07290109155296Sapphire PCA Lockbox 500mL Label EITAN MEDICAL LTDMRZ2024-11-29
15019517375244CADDICU MEDICAL, INC.MRZ2024-10-14
1729010915261250/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
17290109152629Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
2729010915261950/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
27290109152626Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
B553202191OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202192OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202193OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202091OTC0Health OptimizerWELLDOC, INC.MRZ2024-03-28
B553202092OTC0Health OptimizerWELLDOC, INC.MRZ2024-03-28
17290109151653PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
27290109151650PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
17290109154104Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
27290109154101Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
B553202093OTC0Health OptimizerWELLDOC, INC.MRZ2024-01-26
B553HLTHOPTIMIZER190Health OptimizerWELLDOC, INC.MRZ2024-01-26
B553HLTHOPTIMIZER180Health OptimizerWELLDOC, INC.MRZ2023-11-17
00850025535502UTC 3ml Medication CartridgeGilero, LLCMRZ2023-09-25
17290109154708Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05
27290109154705Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05