Trulink 700-0007-37
GUDID 10841522103698
LDWR SET,SNAP,ECG,29IN,A AMI,5LW/SET,1/SET
SPACELABS HEALTHCARE (WASHINGTON), INC
Electrocardiographic lead set, reusable| Primary Device ID | 10841522103698 |
| NIH Device Record Key | 1b2ef9a3-698d-46d3-913b-2fa1e4527e9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trulink |
| Version Model Number | AMC |
| Catalog Number | 700-0007-37 |
| Company DUNS | 145581588 |
| Company Name | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| 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 |
| 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 |
| 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 |
| 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 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841522103698 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103142
FDA Product Code
| DSI | DETECTOR AND ALARM, ARRHYTHMIA |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2023-06-13 |
| Device Publish Date | 2016-10-10 |
On-Brand Devices [Trulink]
| 10841522101069 | NIBP,CUFF,1TB,LG.ADULT-LONG,31-40CM,NYLON,1/EA |
| 10841522101052 | NIBP,CUFF,1TB,ADULT-LONG,23-33CM,NYLON,1/EA |
| 10841522101045 | NIBP,CUFF,1TB,SM.ADULT-LONG,17-25CM,NYLON,1/EA |
| 10841522101038 | NIBP,CUFF,1TB,CHILD-LONG,12-19CM,NYLON,1/EA |
| 10841522101021 | NIBP,CUFF,1TB,THIGH,38-50CM,NYLON,1/EA |
| 10841522101014 | NIBP,CUFF,1TB,LG.ADULT,31-40CM,NYLON,1/EA |
| 30841522101179 | NIBP,CUFF,1TB,LG.ADULT-LONG,23-33CM,VINYL |
| 30841522101162 | NIBP,CUFF,1TB,NEO5,8-15CM,SOFT |
| 30841522101155 | NIBP,CUFF,1TB,NEO4,7-13CM,SOFT |
| 30841522101148 | NIBP,CUFF,1TB,NEO3,6-11CM,SOFT |
| 30841522101131 | NIBP,CUFF,1TB,NEO2,4-8CM,SOFT |
| 30841522101124 | NIBP,CUFF,1TB,NEO1,3-6CM,SOFT |
| 30841522101117 | NIBP,CUFF,1TB,THIGH,38-50CM,VINYL |
| 30841522101100 | NIBP,CUFF,1TB,LG.ADULT,31-40CM,VINYL |
| 30841522101094 | NIBP,CUFF,1TB,ADULT,23-33CM,VINYL |
| 30841522101087 | NIBP,CUFF,1TB,SM.ADULT,17-25CM,VINYL |
| 30841522101070 | NIBP,CUFF,1TB,CHILD,12-19CM,VINYL |
| 10841522101007 | NIBP,CUFF,1TB,ADULT,23-33CM,NYLON |
| 10841522100994 | NIBP,CUFF,1TB,SM.ADULT,17-25CM,NYLON,1/EA |
| 10841522100987 | NIBP,CUFF,1TB,CHILD,12-19CM,NYLON,1/EA |
| 10841522110610 | CABLE,ECG,SHIELDED,10-LEAD,305CM/10 FT,AAMI |
| 10841522110399 | LDWR,SET,SHLD,PNCH,10-LD,102CM/40IN,AAMI,1/ST |
| 10841522110337 | LDWR,SET,PINCH,10-LEAD,61CM/24IN,AAMI,1/ST |
| 10841522110238 | LDWR,SET,SHLD,PNCH,3-LEAD,102CM/40IN,AAMI,1/ST |
| 10841522103728 | CABLE,ECG,SHIELDED,3-LEA D,305CM/10 FT,AAMI |
| 10841522103674 | LDWR,SET,SHLD,SNAP,5-LEA D,102CM/40IN,AAMI,1/ST |
| 10841522103650 | LDWR,SET,SNAP,61CM/24IN, AAMI,5LW/ST,1/ST |
| 10841522103544 | LDWR,SET,SHLD,PNCH,3-LEA D,61CM/24IN,AAMI,1/ST |
| 10841522102219 | LDWR,INDV,SHLD,SNAP,BLACK,102CM/40IN,IEC,3/PK |
| 10841522102202 | LDWR,INDV,SHLD,SNAP,WHITE,102CM/40IN,IEC,3/PK |
| 10841522102196 | LDWR,INDV,SHLD,SNAP,GREEN,102CM/40IN,IEC,3/PK |
| 10841522102189 | LDWR,INDV,SHLD,SNAP,RED,102CM/40IN,IEC,3/PK |
| 10841522102172 | LDWR,INDV,SHLD,SNAP,BLACK,61CM/24IN,IEC,3/PK |
| 10841522102165 | LDWR,INDV,SHLD,SNAP,WHITE,61CM/24IN,IEC,3/PK |
| 10841522102158 | LDWR,INDV,SHLD,SNAP,GREEN,61CM/24IN,IEC,3/PK |
| 10841522102141 | LDWR,INDV,SHLD,SNAP,RED,61CM/24IN,IEC,3/PK |
| 10841522102097 | LDWR,INDV,SHLD,SNAP,YELLOW,102CM/40IN,IEC,3/PK |
| 10841522101922 | LDWR,INDV,SHLD,SNAP,YELLOW,61CM/24IN,IEC,3/PK |
| 10841522101779 | LDWR,SET,DIN,SNAP,3-LEAD,61CM/24IN,IEC,1/ST |
| 10841522111204 | ADAPTR,TRULINK TM COMB.,5-LEAD,UV,9034X/9134X |
| 10841522122804 | LDWR SET,V LDS,SNAP,ECG,127CM/50IN,5LW/SET,BX/25 |
| 10841522122774 | LDWR SET,SNAP,ECG,127CM/50 IN,3LW/SET,BX/25 |
| 10841522122736 | LDWR SET,V LDS,PINCH,ECG,127CM/50IN,4LW/ST,BX/25 |
| 10841522122699 | LDWR SET SNAP,ECG,50IN,AAMI,6LW/SET BX/25 |
| 10841522111082 | LDWR SET,SNAP,ECG 29IN,AAMI,6LW/SET,1/SET |
| 10841522111068 | LDWR SET,V LDS,SNAP,ECG,74CM/29IN,5LW/SET,1/SET |
| 10841522110870 | LDWR SET,V LDS,PINCH,ECG,74CM/29IN,4LW/SET,1/SET |
| 10841522102066 | LDWR,INDV,SHLD,SNAP,GRN/WHT,61CM/24IN,IEC,3/PK |
| 10841522102035 | LDWR,INDV,SHLD,SNAP,ORG/BRWN,61CM/24IN,AAMI,3/PK |
| 10841522102004 | LDWR,INDV,SHLD,SNAP,YLW/BRWN,61CM/24IN,AAMI,3/PK |
Trademark Results [Trulink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRULINK 88902673 not registered Live/Pending |
Schlumberger Technology Corporation 2020-05-06 |
 TRULINK 88775835 not registered Live/Pending |
Applied System Technologies, Inc. 2020-01-28 |
 TRULINK 87544914 5460719 Live/Registered |
Custom Dynamics, LLC 2017-07-27 |
 TRULINK 87433121 5345816 Live/Registered |
SPACELABS HOLDINGS, INC. 2017-05-02 |
 TRULINK 86249365 5027535 Live/Registered |
Starkey Laboratories, Inc. 2014-04-11 |
 TRULINK 85775892 4452430 Live/Registered |
Pengo Corporation 2012-11-09 |
 TRULINK 85626576 not registered Dead/Abandoned |
METRA ELECTRONICS CORPORATION 2012-05-16 |
 TRULINK 85617183 not registered Dead/Abandoned |
METRA ELECTRONICS CORPORATION 2012-05-04 |
 TRULINK 78959615 3376617 Dead/Cancelled |
BAUSCH & LOMB INCORPORATED 2006-08-24 |
 TRULINK 78920218 3532645 Live/Registered |
ORTRONICS, INC. 2006-06-29 |
 TRULINK 78348273 3218558 Live/Registered |
Telephonics Corporation 2004-01-06 |
 TRULINK 74443862 1844284 Live/Registered |
SPACELABS HOLDINGS, INC. 1993-10-04 |
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