FDA.reportPublic FDA data

Life-Stat

Primary DI
00860682000121
Brand
Life-Stat
Company
MICHIGAN INSTRUMENTS, LLC
Model
1008MII
Catalog number
16000
Device description
External Cardiac Compressor - Life-Stat Model 1008MII
Published
2014-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRMCompressor, Cardiac, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRMCompressor, Cardiac, ExternalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073079000THUMPER, MODEL: 1008Michigan Instruments, Inc.2008-02-14DRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860682000121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860682000121008606820001218606820001210860682000121

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac resuscitator, pneumaticA pneumatically-powered external device designed for the application of rhythmic compression to the chest in the region of the heart to provide blood flow during treatment of cardiac arrest [cardiopulmonary resuscitation (CPR)]. It is typically powered from medical gas cylinders or a medical gas pipeline system and may consist of a solid base with an attached band that straps across the patient's chest to produce the compressions, or have other configurations. The device is typically used as an adjunct to or substitute for manual external cardiac compression, to prevent fatigue and to provide better consistency in the applied force and rate of compression.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
616-554-9696mii@michinst.com

Regulatory Flags#

DUNS number
081208064
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860682000114Thumper1007CCV153702014-09-12
00860682000107Thumper1007CCMII153502014-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10815098020819Defibtech ARM XR Compression Module ConfigurationDEFIBTECH, L.L.C.DRM2025-03-25
00883873834282LUCAS CPR Chest Compression SystemJolife ABDRM2024-11-08
00883873762370LUCAS CHEST COMPRESSION SYSTEMPHYSIO-CONTROL, INC.DRM2024-05-31
00883873762387LUCASPHYSIO-CONTROL, INC.DRM2024-05-31
00883873826300LUCAS CHEST COMPRESSION SYSTEMJolife ABDRM2024-05-07
00883873826584LUCAS CHEST COMPRESSION SYSTEMJolife ABDRM2024-05-07
00849111002998AutoPulse Li-ion BatteryZoll Circulation, Inc.DRM2023-10-17
00849111003032AutoPulse NXTZoll Circulation, Inc.DRM2023-10-17
10849111002988LifeBand® Load-distributing BandZoll Circulation, Inc.DRM2023-10-17
00849111002981LifeBand® Load-distributing BandZoll Circulation, Inc.DRM2023-10-16
00849111003018AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.DRM2023-10-13
00849111003025AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.DRM2023-10-13
00849111003049AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.DRM2023-10-13
00849111003384AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.DRM2023-10-13
00849111003568AutoPulse NXT Multi-Chemistry Battery ChargerZoll Circulation, Inc.DRM2023-10-13
00815098020812Defibtech ARM XR Compression ModuleDEFIBTECH, L.L.C.DRM2023-01-25
00815098020829Defibtech ARM XR Stabilization StrapDEFIBTECH, L.L.C.DRM2023-01-25
00815098020836Defibtech ARM XR Suction Cup DEFIBTECH, L.L.C.DRM2023-01-25
00849111003223AutoPulse®Resuscitation SystemZoll Circulation, Inc.DRM2022-08-15
10849111003053AutoPulse®Resuscitation SystemZoll Circulation, Inc.DRM2022-08-15
00847946024048REUSABLE AIRWAY ADAPTERZoll Medical CorporationDRM2021-10-05
00847946024055REUSABLE AIRWAY ADAPTERZoll Medical CorporationDRM2021-10-05
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00860000876254ROSC-U Battery ChargerRESUSCITATION INTERNATIONAL, LLCDRM2019-12-13
00860000876261ROSC-U Head StabilizerRESUSCITATION INTERNATIONAL, LLCDRM2019-12-13
00860000876278ROSC-U Carrying/Storage CaseRESUSCITATION INTERNATIONAL, LLCDRM2019-12-13