FDA.reportPublic FDA data

Surge Cardiovascular

Primary DI
00817278010125
Brand
Surge Cardiovascular
Company
Med Michigan Holdings, LLC
Model
213-004
Catalog number
213-004
Device description
8-Hole Tubing Organizer with Clips
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRIAccessory Equipment, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817278010122PackageGS125In Commercial Distribution
00817278010125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081727801012210817278010122
00817278010125008172780101258172780101250817278010125

GMDN Terms#

Term, Definition table
TermDefinition
Medical/surgical interventional tube/cable securement clip, single-useA device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters, irrigation tubing) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
097462979
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817278010118Surge Cardiovascular213-002213-0022016-09-23
00817278010958Surge Cardiovascular213-003213-0032016-09-23
00817278010965Surge Cardiovascular213-003NS213-003NS2016-09-23
00817278012341Surge CardiovascularFEM-V1020FEM-V10202017-10-30
00817278012358Surge CardiovascularFEM-V1022FEM-V10222017-10-30
00817278012365Surge CardiovascularFEM-V1024FEM-V10242017-10-30
00817278012372Surge CardiovascularFEM-V1026FEM-V10262017-10-30
00817278012389Surge CardiovascularFEM-V1028FEM-V10282017-10-30
00817278012020Patriot ProPP-BLM-22150PP-BLM-221502024-06-04
00817278010002Surge CardiovascularSUT-010SUT-0102016-09-23
00817278010019Surge CardiovascularSUT-013SUT-0132016-09-23
00817278010026Surge Cardiovascular213-013213-0132016-09-23
00817278010156Surge Cardiovascular215-015215-0152016-09-23
00817278010163Surge Cardiovascular215-030215-0302016-09-23
00817278010170Surge Cardiovascular215-044215-0442016-09-23
00817278010224Surge CardiovascularACIPACIP2016-09-23
00817278010231Surge CardiovascularANT-1014SANT-1014S2016-09-23
00817278010248Surge CardiovascularANT-2012SANT-2012S2016-09-23
00817278010255Surge CardiovascularANT-2014SANT-2014S2016-09-23
00817278010262Surge CardiovascularCAR-1613SCAR-1613S2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974762682221LifemotionLifemotion Medical Technology Co., Ltd.KRI2026-06-05
06974762681101LifemotionLifemotion Medical Technology Co., Ltd.KRI2026-06-02
18051160302137Quantum Perfusion Capnometer Line SetSPECTRUM MEDICAL SRLKRI2026-05-21
28051160301564Quantum PureFlow KIT CPC - Barbed Connector AdaptorSPECTRUM MEDICAL SRLKRI2026-05-21
28051160301571Quantum PureFlow KIT CPC - Hansen Connector AdaptorSPECTRUM MEDICAL SRLKRI2026-05-21
08052595517144HOLDEREUROSETS SRLKRI2026-05-05
08052595517458HOLDEREUROSETS SRLKRI2026-05-05
08052595517465HOLDEREUROSETS SRLKRI2026-05-05
05060434424457QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-20
05060434424532QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-09
05415067034441CentriMag™Thoratec CorporationKRI2026-02-02
00850054036629Cardio Quip VivaCart Short Infusion Pole with Removable HooksCARDIOQUIP, LLCKRI2025-10-28
08034013785489HOLDEREUROSETS SRLKRI2025-02-19
07290117830079INSPIRA CARTINSPIRA TECHNOLOGIES OXY B.H.N LTDKRI2024-11-10
17290117830076INSPIRA CARTINSPIRA TECHNOLOGIES OXY B.H.N LTDKRI2024-11-10
10850007732353VitalFlow CaddyMICHIGAN CRITICAL CARE CONSULTANTS, INC.KRI2024-09-19
05060434423962QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
05060434423979QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
05060434423986Quantum SPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423966QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423973QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423980Quantum SPECTRUM MEDICAL LIMITEDKRI2023-12-22
08033178101547Sinergy and Mini Bag CPBSORIN GROUP ITALIA SRLKRI2023-10-24
08033178101622Vanguard, CSC 14 and HSCSORIN GROUP ITALIA SRLKRI2023-10-24
08033178102292DAC CardiotomySORIN GROUP ITALIA SRLKRI2023-10-24
08033178102384ExchangerSORIN GROUP ITALIA SRLKRI2023-10-24
08033178103428HemoconcentratorSORIN GROUP ITALIA SRLKRI2023-10-24
08033178109857D100/D101SORIN GROUP ITALIA SRLKRI2023-10-24
08033178109864D130/D131 KIDS Arterial FilterSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111959InspireSORIN GROUP ITALIA SRLKRI2023-10-24