FDA.reportPublic FDA data

SAVe1 Conversion Kit

Primary DI
M6892511050020
Brand
SAVe1 Conversion Kit
Company
Safeguard US Operating, LLC
Model
02
Catalog number
25-110-50
Device description
Automedx Conversion Kit
Published
2018-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6892511050020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator IMV supplemental circuit, single-useA device designed to provide mandatory breathes to ventilator patients to supplement the spontaneous respiratory rate. It is typically constructed of plastics and consists of tubing and one-way valves. It will be used as an accessory on older ventilators without built-in intermittent mandatory ventilation (IMV) functions. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-428-6074fulfillment@combatmedical.com

Regulatory Flags#

DUNS number
118492643
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M689PBEFAK010Point Blank Enterprises Employee FAK - Private Label01PBEFAK2026-07-09
M689SHSTARTPAXSM030SCHOOL TRAUMA ADVANCED RESPONSE KIT03SH-START-PAX-SM2026-06-22
M689SHSTARTSM030School Trauma Active Response Kit03SH-START-SM2026-06-22
M68988441050Mojo Multi Mission Bag - Basic0584-4412019-10-31
M689GOIO040GO IO Intraosseous Start Kit 12/Case04GO IO2024-12-12
M68980100150INTRAVENOUS INFUSION STARTER SET1580-1002026-05-04
M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 200480-100-202026-05-04
M68980801D160Fresh Whole Blood Donor Transfusion Set1680-801-D2026-05-04
M68980801R120Fresh Whole Blood Recipient Set1280-801-R2026-05-04
M6898250403050MEDIC ENHANCEMENT SET0582-504-032026-06-03
M689801101006080-110-10 Saline Lock Kit Case of 100680-110-102026-05-29
M68980110150SALINE LOCK KIT1580-1102026-05-29
M6898143003020Maritime Boat Box - Advanced0281-430-032026-05-28
M6898444601190Mojo Multi Mission - Advanced1984-446-012026-05-27
M689HHCTUINK01050Chest Tube Insertion Kit05HHCTUINK012026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 505HHCTUINK01-052026-05-27
M689801101005080-110-10 Saline Lock Kit Case of 100580-110-102025-04-16
M68980110140SALINE LOCK KIT1480-1102025-01-11
M6898143003010Maritime Boat Box - Advanced0181-430-032025-07-11
M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012402691Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
09420012433756Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
10197344011346HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011353HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011377HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
09420012479105F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479129F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479143F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479167F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
10889483225653AirLife™SUNMED, LLCBZO2025-12-19
09420012414885AdaptorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2025-10-07
14026704929099GIBECKTELEFLEX INCORPORATEDBZO2025-07-30
14026704660978HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-07
10889483570555AirLife™AIRLIFEBZO2025-03-27
10889483571675AirLife™AIRLIFEBZO2025-03-27
10889483571682AirLife™AIRLIFEBZO2025-03-27
10889483571699AirLife™AIRLIFEBZO2025-03-27
10889483572160AirLife™AIRLIFEBZO2025-03-27
10889483588246AirLife™AIRLIFEBZO2025-03-27
10889483570227AirLife™AIRLIFEBZO2025-03-18
10889483570289AirLife™AIRLIFEBZO2025-03-18
10889483570326AirLife™AIRLIFEBZO2025-03-18
10889483570517AirLife™AIRLIFEBZO2025-03-06
10889483571705AirLife™AIRLIFEBZO2025-03-05
10889483570548AirLife™AIRLIFEBZO2025-02-26
10889483570708AirLife™AIRLIFEBZO2025-02-26
10889483570173AirLife™AIRLIFEBZO2025-02-25
10889483570197AirLife™AIRLIFEBZO2025-02-25
10889483570203AirLife™AIRLIFEBZO2025-02-25
10889483570210AirLife™AIRLIFEBZO2025-02-25