Trulink 700-0006-08

GUDID 10841522103568

LDWR,SET,SHLD,PNCH,5-LEA D,61CM/24IN,AAMI,1/ST

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable
Primary Device ID10841522103568
NIH Device Record Key36763072-de2b-43ad-a607-750255674a6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrulink
Version Model Number91496
Catalog Number700-0006-08
Company DUNS145581588
Company NameSPACELABS HEALTHCARE (WASHINGTON), INC
Device Count1
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
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110841522103568 [Primary]
GS110841522103568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDETECTOR AND ALARM, ARRHYTHMIA
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 Date2020-05-19
Device Publish Date2017-03-07

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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