X SERIES

GUDID 00847946050405

MAIN ASSY, X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACE, SPO2, ETCO2, IBP, TEMP, BVM, NIBP, CPR EXPANSION PACK, SWISS FRENCH

Zoll Medical Corporation

Physiologic-monitoring defibrillation system

Primary Device ID	00847946050405
NIH Device Record Key	d8ac2dfa-0e76-4c75-8c7d-e692c0e5e25c
Commercial Distribution Status	In Commercial Distribution
Brand Name	X SERIES
Version Model Number	630-0221711-42
Company DUNS	055363428
Company Name	Zoll Medical Corporation
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Handling Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Handling Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Handling Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Handling Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Handling Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Handling Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Handling Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 0 KiloPascal and 0
Handling Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946050405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112432

FDA Product Code

CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-07-08
Device Publish Date	2022-06-30

On-Brand Devices [X SERIES]

00847946099657	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, SPCO, TEM
00847946099558	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946099541	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946099534	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946099497	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, PACING, NIBP, SPO2,
00847946099442	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, IBP/TEMP, PACING, NI
00847946099404	Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, NIBP, TEMP, ETCO2, DMST
00847946099398	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946099374	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACING, SPO2, CPR EXPANSION PACK, DMST
00847946099299	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LD, NIBP, SPO2, SPCO, SPMET, CPR EXTENDED, DMST
00847946099282	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD, PACING, NIBP, SPO2, ETCO2, DOMESTIC
00847946026462	Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W/PACING ,NELLCOR, 3/5 LEAD, SPO2, NIBP, IBP/TEMP,
00847946026455	Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP, CPR E
00847946026325	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, C
00847946024451	Defibrillator ,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, CPR EX
00847946024383	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946024314	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NELLCOR, IBP/TEMP, PACING, NI
00847946024260	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, PACING, NO NIBP, SPO2, ETCO2,
00847946024253	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, E
00847946023614	DEVICE IDENTIFIER,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, SPO2, CPR EXPANSION PACK AND
00847946023607	DEVICE IDENTIFIER,X SERIES, ALS, 12 LD, PACE, NELLCOR, SPO2, SPCO, SPMET, ETCO2, IBP/TEMP, NIBP,
00847946023591	DEVICE IDENTIFIER,X SERIES, ALS, 12 LD, PACE, NELLCOR, SPO2, SPCO, SPMET, ETCO2, TEMP, NIBP, CPR
00847946023584	DEVICE IDENTIFIER,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, CPR., DMST
00847946023577	DEVICE IDENTIFIER,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, SPO2, CPR EXPANSION PACK AND
00847946023560	DEVICE IDENTIFIERX SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP
00847946023553	DEVICE IDENTIFIER,X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP
00847946020538	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, W/PACING, SPO2, ETCO2, IBP, NIBP, CPR EXPANS
00847946020514	X SERIES MONITOR/DEFIBRILLATOR W/PACING,VOICE,12 LEAD W/INTERP, SPO2, NIBP, CPR EXPANSION PACK,
00847946020507	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, TEMP, CPR EXPANSION PACK
00847946020491	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, SPMET, SPH
00847946020484	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, SPMET, IBP
00847946020477	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, CPR EXPANS
00847946020460	X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION P
00847946020453	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, CPR EXPANSION PA
00847946020446	X SERIES, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, SPO2, NIBP, TEMP, CPR EXPANSION PACK,
00847946020439	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, PACING, NIBP, SPO2, IBP/TEMP, CPR EXPANSION
00847946020422	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, SPCO, CPR
00847946020385	MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, DMST, REFURB
00847946020309	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP MOD-G, SPO2, AND
00847946020286	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, VOICE, NIBP,
00847946020279	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NO NIBP, SPO2
00847946020262	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, CPR DASHBOARD, DMST
00847946020255	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, CPR EXPAN
00847946020248	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946020231	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946020149	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946020132	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946020019	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, DMST
00847946019990	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, S
00847946019983	Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, DMST

Trademark Results [X SERIES]

Mark Image Registration \| Serial	Company Trademark Application Date
X SERIES 97788771 not registered Live/Pending	Topgolf Callaway Brands Corp. 2023-02-09
X SERIES 90390796 not registered Live/Pending	Artisan Industries, Inc. 2020-12-17
X SERIES 90376394 not registered Live/Pending	Callaway Golf Company 2020-12-11
X SERIES 88640315 not registered Live/Pending	Southeast Toyota Distributors, LLC 2019-10-03
X SERIES 88609223 not registered Live/Pending	Lead Pro Inc. 2019-09-09
X SERIES 88514518 not registered Live/Pending	Riton USA, LLC 2019-07-15
X SERIES 88504108 not registered Live/Pending	C.R. Onsrud, Inc. 2019-07-08
X SERIES 88441488 not registered Live/Pending	MacroAir Technologies, Inc. 2019-05-22
X SERIES 88369880 not registered Live/Pending	Callaway Golf Company 2019-04-03
X SERIES 88109084 not registered Dead/Abandoned	Target Completions, LLC 2018-09-07
X SERIES 88087912 not registered Live/Pending	Zimmer Surgical, Inc. 2018-08-22
X SERIES 87935233 not registered Live/Pending	8x8, Inc. 2018-05-24