ZOLL ADAPTOR

GUDID 00847946016814

Zoll Medical Corporation

Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946016814
• NIH Device Record Key: 679ac7c4-cc81-4335-80ad-b74e3384a955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOLL ADAPTOR
• Version Model Number: 1005-0100
• Company DUNS: 055363428
• Company Name: Zoll Medical Corporation
• 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: 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	00847946016814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112432

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: 2014-09-23

Devices Manufactured by Zoll Medical Corporation

• 10847946027015 - GEMINI: 2025-03-03 ONESTEP PEDIATRIC CPR ELECTRODE, GEMINI, 8/CASE
• 00812394026043 - M330: 2025-02-04 ASPIRATOR, M330, US AIR FORCE, W/O BAG
• 00847946034085 - ZENIX: 2025-01-08 ASSEMBLY, ONESTEP CONNECTOR, ZENIX
• 00847946034092 - ZENIX: 2024-12-25 ASSEMBLY, GREEN CONNECTOR, ZENIX
• 00847946056094 - ZENIX: 2024-12-20 CABLE, LIMB LEAD ECG, IEC
• 00847946033965 - ZENIX: 2024-11-21 CABLE, ECG 3 LEAD SET, IEC
• 00847946027018 - CPR ELECTRODE, GEMINI: 2024-11-11 ONESTEP PEDIATRIC CPR ELECTRODE, GEMINI, SINGLE
• 00847946094706 - VENT: 2024-07-26 ZVENT, FULL FEATURED, HOSPITAL SW w/CARRY CAGE, RENTAL PROGRAM