Replacement Kit for CHARGE-PAK battery charger 11403-000002

GUDID 00883873824597

SHIPPING ASSY-C-P, Q-P,REPL KIT, 1 ELECTRODE

PHYSIO-CONTROL, INC.

External defibrillator electrode, adult, single-use

• Primary Device ID: 00883873824597
• NIH Device Record Key: b7fe1a45-34ae-4a68-89a9-fa5130b9998d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Replacement Kit for CHARGE-PAK battery charger
• Version Model Number: 11403
• Catalog Number: 11403-000002
• Company DUNS: 009251992
• Company Name: PHYSIO-CONTROL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883873824597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160012

FDA Product Code

• MKJ: Automated external defibrillators (non-wearable)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-28
• Device Publish Date: 2023-02-20

On-Brand Devices [Replacement Kit for CHARGE-PAK battery charger]

• 00721902514128: SHIPPING ASSY-C-P, Q-P,REPL KIT, 1 ELECTRODE
• 00883873824597: SHIPPING ASSY-C-P, Q-P,REPL KIT, 1 ELECTRODE