ECG

GUDID 00847946021832

ASSY, CABLE, 12 LEAD ECG LIMB LEAD, 10FT, AAMI, BLACK

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946021832
• NIH Device Record Key: bae6371e-ecba-4113-837b-d948b330a6cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG
• Version Model Number: 9500-1527-03
• Company DUNS: 055363428
• Company Name: Zoll Medical Corporation
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946021832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062537

FDA Product Code

• DRT: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [ECG]

• 00847946023294: DEVICE IDENTIFIER,CABLE, ECG, 5-LEAD, AAMI
• 00847946023249: CABLE, 3 LEAD, ECG/ESU, R SERIES
• 00847946021849: 12 LEAD ECG LIMB LEAD, 7FT BLACK
• 00847946021832: ASSY, CABLE, 12 LEAD ECG LIMB LEAD, 10FT, AAMI, BLACK
• 00847946021825: 12 LEAD ECG LIMB LEAD, 7FT BLACK
• 00847946021818: 12 LEAD ECG LIMB LEAD, 10FT BLACK
• 00847946021801: CABLE, V LEAD ECG, AAMI, PROPAQ MD
• 00847946021795: CABLE, 5 LEAD ECG, AAMI, PROPAQ MD
• 00847946021788: CABLE, 3 LEAD ECG, AAMI, PROPAQ MD
• 00847946021771: CABLE, LIMB LEAD ECG, AAMI, PROPAQ MD
• 00847946021764: CABLE, 12 LEAD ECG, AAMI, PROPAQ MD
• 00847946021757: PLUG, PORT, V-LEAD, BLACK
• 00847946021740: PLUG, PORT, V-LEAD, BLACK
• 00847946021733: V-LEAD PATIENT CABLE FOR 12-LEAD ECG (2.5 FT)
• 00847946021726: V-LEAD PATIENT CABLE FOR 12-LEAD ECG (3.5 FT)
• 00847946021696: DEVICE IDENTIFIER,CABLE, ECG, 5-LEAD, AAMI
• 00847946021665: ONESTEP ECG LEADS - AHA (3-LEAD ECG ONLY)
• 00847946021658: LIMB-LEAD PATIENT CABLE FOR 12-LEAD ECG (7 FT)
• 00847946021641: LIMB-LEAD PATIENT CABLE FOR 12-LEAD ECG (10 FT)
• 00847946021634: 1-STEP PATIENT CABLE FOR 12-LEAD ECG WITH LIMB-LEAD AND V-LEAD CABLES (7 FT)
• 00847946021627: 1-STEP PATIENT CABLE FOR 12-LEAD ECG WITH LIMB-LEAD AND V-LEAD CABLES(10 FT)
• 00847946021566: CABLE, V LEAD ECG, IEC, PROPAQ MD
• 00847946021559: CABLE, V LEAD ECG, AAMI, PROPAQ MD
• 00847946021504: CABLE, 5 LEAD ECG, IEC, X SERIES
• 00847946021498: CABLE, 5 LEAD ECG, IEC, PROPAQ MD
• 00847946021481: CABLE, 5 LEAD ECG, AAMI, PROPAQ MD
• 00847946021474: CABLE, 3 LEAD ECG, IEC, PROPAQ MD
• 00847946021467: CABLE, 3 LEAD ECG, AAMI, PROPAQ MD
• 00847946021450: CABLE, LIMB LEAD ECG, IEC, PROPAQ MD
• 00847946021443: CABLE, LIMB LEAD ECG, AAMI, PROPAQ MD
• 00847946021436: CABLE, 12 LEAD ECG, IEC, PROPAQ MD
• 00847946021429: CABLE, 12 LEAD ECG, AAMI, PROPAQ MD
• 00847946021252: V-LEAD PATIENT CABLE FOR 12-LEAD ECG (2.5 FT)
• 00847946021245: V-LEAD PATIENT CABLE FOR 12-LEAD ECG (3.5 FT)