Trulink 012-0295-40

GUDID 10841522101489

LDWR,INDV,DIN,SNAP,BROWN,46CM/18IN,AAMI,3/PK

SPACELABS HEALTHCARE (WASHINGTON), INC

Electrocardiographic lead set, reusable

• Primary Device ID: 10841522101489
• NIH Device Record Key: 9f1c0cdd-8f2f-41ee-8ac7-3318f918082c
• Commercial Distribution Discontinuation: 2018-04-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Trulink
• Version Model Number: 90470
• Catalog Number: 012-0295-40
• Company DUNS: 145581588
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Device Count: 3
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841522101482 [Unit of Use]
GS1	10841522101489 [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: 5
• Public Version Date: 2024-06-06
• Device Publish Date: 2016-12-20

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