FDA.reportPublic FDA data

LifeBand® Load-distributing Band

Primary DI
10849111001769
Brand
LifeBand® Load-distributing Band
Company
Zoll Circulation, Inc.
Model
100
Catalog number
8700-0706-24
Device description
Single-use chest compression band. (3 per package)
Published
2015-07-24
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
DRMCompressor, Cardiac, External

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112998000AUTOPULSE RESUSCITATION SYSTEM MODEL 1000Zoll Circulation2012-03-15DRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849111001769PrimaryGS10
00849111001816Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084911100176910849111001769
00849111001816008491110018168491110018160849111001816

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac resuscitator bandA wide belt intended to be applied across the chest as part of an automated cardiac resuscitator, 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)]. The device is typically used on adult patients only and may be adjusted to accommodate a range of chest circumferences. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
4085412140udisj@zoll.com

Regulatory Flags#

DUNS number
799455241
Device count
3
Lot or batch
true
Manufacturing 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
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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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