Trulink 012-0498-26

GUDID 10841522102097

LDWR,INDV,SHLD,SNAP,YELLOW,102CM/40IN,IEC,3/PK

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiographic lead set, reusable
Primary Device ID10841522102097
NIH Device Record Key69c3d9cb-1882-40d1-ab45-df913f81a3f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrulink
Version Model Number90492
Catalog Number012-0498-26
Company DUNS145581588
Company NameSPACELABS HEALTHCARE (WASHINGTON), INC
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100841522102090 [Unit of Use]
GS110841522102097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDETECTOR AND ALARM, ARRHYTHMIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-21
Device Publish Date2016-12-20

On-Brand Devices [Trulink]

10841522101069NIBP,CUFF,1TB,LG.ADULT-LONG,31-40CM,NYLON,1/EA
10841522101052NIBP,CUFF,1TB,ADULT-LONG,23-33CM,NYLON,1/EA
10841522101045NIBP,CUFF,1TB,SM.ADULT-LONG,17-25CM,NYLON,1/EA
10841522101038NIBP,CUFF,1TB,CHILD-LONG,12-19CM,NYLON,1/EA
10841522101021NIBP,CUFF,1TB,THIGH,38-50CM,NYLON,1/EA
10841522101014NIBP,CUFF,1TB,LG.ADULT,31-40CM,NYLON,1/EA
30841522101179NIBP,CUFF,1TB,LG.ADULT-LONG,23-33CM,VINYL
30841522101162NIBP,CUFF,1TB,NEO5,8-15CM,SOFT
30841522101155NIBP,CUFF,1TB,NEO4,7-13CM,SOFT
30841522101148NIBP,CUFF,1TB,NEO3,6-11CM,SOFT
30841522101131NIBP,CUFF,1TB,NEO2,4-8CM,SOFT
30841522101124NIBP,CUFF,1TB,NEO1,3-6CM,SOFT
30841522101117NIBP,CUFF,1TB,THIGH,38-50CM,VINYL
30841522101100NIBP,CUFF,1TB,LG.ADULT,31-40CM,VINYL
30841522101094NIBP,CUFF,1TB,ADULT,23-33CM,VINYL
30841522101087NIBP,CUFF,1TB,SM.ADULT,17-25CM,VINYL
30841522101070NIBP,CUFF,1TB,CHILD,12-19CM,VINYL
10841522101007NIBP,CUFF,1TB,ADULT,23-33CM,NYLON
10841522100994NIBP,CUFF,1TB,SM.ADULT,17-25CM,NYLON,1/EA
10841522100987NIBP,CUFF,1TB,CHILD,12-19CM,NYLON,1/EA
10841522110610CABLE,ECG,SHIELDED,10-LEAD,305CM/10 FT,AAMI
10841522110399LDWR,SET,SHLD,PNCH,10-LD,102CM/40IN,AAMI,1/ST
10841522110337LDWR,SET,PINCH,10-LEAD,61CM/24IN,AAMI,1/ST
10841522110238LDWR,SET,SHLD,PNCH,3-LEAD,102CM/40IN,AAMI,1/ST
10841522103728CABLE,ECG,SHIELDED,3-LEA D,305CM/10 FT,AAMI
10841522103674LDWR,SET,SHLD,SNAP,5-LEA D,102CM/40IN,AAMI,1/ST
10841522103650LDWR,SET,SNAP,61CM/24IN, AAMI,5LW/ST,1/ST
10841522103544LDWR,SET,SHLD,PNCH,3-LEA D,61CM/24IN,AAMI,1/ST
10841522102219LDWR,INDV,SHLD,SNAP,BLACK,102CM/40IN,IEC,3/PK
10841522102202LDWR,INDV,SHLD,SNAP,WHITE,102CM/40IN,IEC,3/PK
10841522102196LDWR,INDV,SHLD,SNAP,GREEN,102CM/40IN,IEC,3/PK
10841522102189LDWR,INDV,SHLD,SNAP,RED,102CM/40IN,IEC,3/PK
10841522102172LDWR,INDV,SHLD,SNAP,BLACK,61CM/24IN,IEC,3/PK
10841522102165LDWR,INDV,SHLD,SNAP,WHITE,61CM/24IN,IEC,3/PK
10841522102158LDWR,INDV,SHLD,SNAP,GREEN,61CM/24IN,IEC,3/PK
10841522102141LDWR,INDV,SHLD,SNAP,RED,61CM/24IN,IEC,3/PK
10841522102097LDWR,INDV,SHLD,SNAP,YELLOW,102CM/40IN,IEC,3/PK
10841522101922LDWR,INDV,SHLD,SNAP,YELLOW,61CM/24IN,IEC,3/PK
10841522101779LDWR,SET,DIN,SNAP,3-LEAD,61CM/24IN,IEC,1/ST
10841522111204ADAPTR,TRULINK TM COMB.,5-LEAD,UV,9034X/9134X
10841522122804LDWR SET,V LDS,SNAP,ECG,127CM/50IN,5LW/SET,BX/25
10841522122774LDWR SET,SNAP,ECG,127CM/50 IN,3LW/SET,BX/25
10841522122736LDWR SET,V LDS,PINCH,ECG,127CM/50IN,4LW/ST,BX/25
10841522122699LDWR SET SNAP,ECG,50IN,AAMI,6LW/SET BX/25
10841522111082LDWR SET,SNAP,ECG 29IN,AAMI,6LW/SET,1/SET
10841522111068LDWR SET,V LDS,SNAP,ECG,74CM/29IN,5LW/SET,1/SET
10841522110870LDWR SET,V LDS,PINCH,ECG,74CM/29IN,4LW/SET,1/SET
10841522102066LDWR,INDV,SHLD,SNAP,GRN/WHT,61CM/24IN,IEC,3/PK
10841522102035LDWR,INDV,SHLD,SNAP,ORG/BRWN,61CM/24IN,AAMI,3/PK
10841522102004LDWR,INDV,SHLD,SNAP,YLW/BRWN,61CM/24IN,AAMI,3/PK

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