FDA.reportPublic FDA data

10.7F PACKAGED ACCUTROL CATHETER

Primary DI
00849111075404
Brand
10.7F PACKAGED ACCUTROL CATHETER
Company
Zoll Circulation, Inc.
Model
NA
Catalog number
8700-000824-01
Device description
The InnerCool Accutrol® Catheter contains an integrated thermistor for temperature feedback and control that eliminates the need for an independently placed temperature-monitoring probe. The Catheter has a polymeric catheter shaft with a radio-opaque flexible distal metallic Temperature Control Element (TCE).
Published
2015-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NCXSystem, Hypothermia, Intravenous, Cooling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCXSystem, Hypothermia, Intravenous, CoolingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080908000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080908000INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEMInnercool Therapies, Inc.- A Delaware Corporation2008-10-17NCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849111075404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849111075404008491110754048491110754040849111075404

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular heating/cooling system catheterA sterile, flexible tube with an attached membrane (e.g., a balloon) intended to be inserted into the central venous system (CVS) to circulate through the membrane a temperature-controlled fluid (e.g., saline solution), in order to heat or cool a patient's blood through the transfer of heat across the membrane. It may have built-in sensors to monitor the patient's body temperature for feedback to a connected control unit. It may be used for body temperature regulation during surgery, intensive care, or for fever management. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10.7French
Length65Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4085412140udisj@zoll.com

Regulatory Flags#

DUNS number
799455241
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849111076296VitalTemp™ VitalTemp™ Universal Pad, 2PK, US8700-0011312025-12-12
10849111076293VitalTemp™ VitalTemp™ Universal Pad, 2PK, US8700-0011312025-12-12
00849111076074Thermogard HQ Surface Start-Up KitSurface Start-Up Kit8700-000935-012024-05-22
00849111076081ThermoGard XP Surface Start-Up KitSurface Start-Up Kit8700-000936-012024-05-22
00849111076128Thermogard™ Vest, S/MS/M8700-000937-012024-05-22
00849111076135Thermogard™ Vest, L/XL L/XL8700-000938-012024-05-22
00849111076098STX SURFACE COOLING S/M PAD8700-000838-012024-08-15
00849111076104STX SURFACE COOLING L/XL PAD 8700-000839-012024-08-15
00849111076111STX SURFACE COOLINGTHIGHS ONLY PAD SET8700-000840-012024-08-15
00849111075787Thermogard XP, Lang set C, RohsThermogardHQ, Lang set C601337-0012023-01-17
00849111075794Thermogard XP, Lang set C, Rohs, RefurbThermogard XP, Lang set C, Rohs, Refurb2023-01-17
00849111075800Thermogard HQTM ConsoleThermogardHQ, Lang set A8700-001030-01 2022-06-27
00849111075862Thermogard HQTM Start-Up KitTG2-500D8700-001027-012022-06-27
00849111075879Thermogard HQTM Start-Up Kit EXTG2-500D, Extended Length8700-001028-012022-06-27
00849111050029Start-Up KitCG-500D8700-0666-032015-03-31
00849111050043ICY-3, Japan, Final Packaged Kit (Applause) IC-38938700-0657-032016-10-10
00849111050050Quattro, Japan, Final Packaged Kit (Applause) IC-45932016-10-10
00849111050074Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)N/A8700-0654-032015-03-31
00849111050081Start-Up Kit JapanCG-500D8700-0785-032016-10-10
00849111075008Thermogard XP®Thermogard XP, Lang set B, Rohs2015-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849111075787Thermogard XP, Lang set C, RohsZoll Circulation, Inc.NCX2023-01-17
00849111075794Thermogard XP, Lang set C, Rohs, RefurbZoll Circulation, Inc.NCX2023-01-17
00849111075800Thermogard HQTM ConsoleZoll Circulation, Inc.NCX2022-06-27
00849111075862Thermogard HQTM Start-Up KitZoll Circulation, Inc.NCX2022-06-27
00849111075879Thermogard HQTM Start-Up Kit EXZoll Circulation, Inc.NCX2022-06-27
00849111050043ICY-3, Japan, Final Packaged Kit (Applause) Zoll Circulation, Inc.NCX2016-10-10
00849111050050Quattro, Japan, Final Packaged Kit (Applause) Zoll Circulation, Inc.NCX2016-10-10
00849111050081Start-Up Kit JapanZoll Circulation, Inc.NCX2016-10-10
00849111075176Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit NeZoll Circulation, Inc.NCX2016-10-10
00849111075183Cool Line® Intravascular Heat Exchange Catheter Kit Non Heparin Custom LuerZoll Circulation, Inc.NCX2015-07-30
00849111075190Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer HeparinZoll Circulation, Inc.NCX2015-07-30
00849111075213Cool Line® Intravascular Heat Exchange Catheter Kit EU Final Packaged Kit CustomZoll Circulation, Inc.NCX2015-07-30
00849111075220ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non HeparinZoll Circulation, Inc.NCX2015-07-30
00849111075237ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin)Zoll Circulation, Inc.NCX2015-07-30
00849111075251ICY® Intravascular Heat Exchange Catheter Kit EU Applause Custom Luer (Heparin)Zoll Circulation, Inc.NCX2015-07-30
00849111075268QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non-HepZoll Circulation, Inc.NCX2015-07-30
00849111075275QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin EZoll Circulation, Inc.NCX2015-07-30
00849111075282QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin)Zoll Circulation, Inc.NCX2015-07-30
00849111075305SOLEX® Intravascular Heat Exchange Catheter Primum Kit Custom Luer Applause HepZoll Circulation, Inc.NCX2015-07-30
00849111075312SOLEX® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin EUZoll Circulation, Inc.NCX2015-07-30
00849111075503Quattro, Heparin, Premium Kit, USZoll Circulation, Inc.NCX2015-07-30
00849111075336Start-Up Kit Custom LuerZoll Circulation, Inc.NCX2015-07-15
00849111075350Start-Up Kit Extended Length, Custom LuerZoll Circulation, Inc.NCX2015-07-15
00849111075381InnerCool RTx 10.7F Standard CatheterZoll Circulation, Inc.NCX2015-07-01
00849111075398InnerCool RTx 14F Standard CatheterZoll Circulation, Inc.NCX2015-07-01
0084911107541114F PACKAGED ACCUTROL CATHETERZoll Circulation, Inc.NCX2015-07-01
00849111075428CATHETER INTRODUCER KIT, 14FZoll Circulation, Inc.NCX2015-07-01
00849111075435CATHETER INTRODUCER KIT, 10.7FZoll Circulation, Inc.NCX2015-07-01
00849111075442RTX CIRCULATING CASSETTE WITH ELECTROLYTEZoll Circulation, Inc.NCX2015-07-01
00849111075459RTX CIRCULATING CASSETTE WITHOUT ELECTROLYTEZoll Circulation, Inc.NCX2015-07-01