FDA.reportPublic FDA data

MADM

Primary DI
10807141000091
Brand
MADM
Company
Thornhill Research Inc
Model
124641
Device description
Assy, MADM
Published
2020-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSZGas-Machine, Anesthesia
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSZGas-Machine, AnesthesiaAnesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140264000MADMThornhill Research, Inc.2015-01-05BSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10807141000091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080714100009110807141000091

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia unit, mobileA stand-alone assembly of devices on wheels for mobility designed to continuously or intermittently administer a mixture of gases [e.g., oxygen (O2), ambient/medical air, nitrous oxide (N2O), anaesthetic agents] to provide a patient with an appropriate level of anaesthesia for a surgical procedure. Also known as an anaesthesia machine, it may include an oxygen concentrator or function with mounted medical gas cylinders, and typically has mechanical gas-delivery devices (e.g., flowmeters and vaporizers). It may incorporate a powered or manual anaesthesia ventilator, a patient breathing circuit, and gas monitoring devices; patient monitors are typically separately mounted (not integral).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-597-1325info@thornhillmedical.com

Regulatory Flags#

DUNS number
205151975
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10807141000022MOVES1012102020-10-01
10807141000046MOVES1012112020-10-01
10807141000008MOVES1006952020-10-01
10807141000015MOVES1006962020-10-01
10807141000060MOVES1115592020-10-01
10807141000077MOVES1115602020-10-01
10807141000084MOVES1242412020-10-01
10807141000107ClearMate1282222020-10-01
10807141000114MOVES SLC1248462020-10-01
10807141000121MOVES SLC1248472020-10-01
10807141000138MOVES1008232020-10-01
10807141000145MOVES1114222020-10-01
10807141000152MOVES1006262020-10-01
10807141000169MOVES1006272020-10-01
20807141000036MOVES1012102020-10-01
20807141000050MOVES1012112020-10-01
18071411242418MOVES1242412015-11-06
18071411243521MOVES1012102015-11-06
18071411243538MOVES1012112015-11-06
18071411282223ClearMate1282222019-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521858077NellcorCovidien LPCCK2026-05-29
10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
10612479282190McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282213McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282237McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282251McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282275McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14