Defibtech ACC Compression Module

GUDID 00815098020621

DEFIBTECH, L.L.C.

Cardiac resuscitator, line-powered Cardiac resuscitator, line-powered

• Primary Device ID: 00815098020621
• NIH Device Record Key: 2801fae1-15bb-45c6-9ca0-40e2f2f78d20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Defibtech ACC Compression Module
• Version Model Number: RMC-E1000
• Company DUNS: 128340200
• Company Name: DEFIBTECH, L.L.C.
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815098020621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141809

FDA Product Code

• DRM: Compressor, Cardiac, External

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: 2015-10-24

On-Brand Devices [Defibtech ACC Compression Module]

• 00815098020621: RMC-E1000
• 00815098020539: RMC-A1000