XLR8 Canister

GUDID 00849405000396

All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system canister

• Primary Device ID: 00849405000396
• NIH Device Record Key: 36b84ab8-0ffb-4a17-b2fb-cfbfd8f62691
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XLR8 Canister
• Version Model Number: A4-S00D2
• Company DUNS: 006616130
• Company Name: GENADYNE BIOTECHNOLOGIES INC.
• 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: 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	00849405000396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143726

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-13
• Device Publish Date: 2024-08-05

On-Brand Devices [XLR8 Canister]

• 00849405000426: All canisters are made out of ABS material. It is used as a disposable item to collect patient�
• 00849405000419: All canisters are made out of ABS material. It is used as a disposable item to collect patient�
• 00849405000402: All canisters are made out of ABS material. It is used as a disposable item to collect patient�
• 00849405000396: All canisters are made out of ABS material. It is used as a disposable item to collect patient�
• 00849405000051: All canisters are made out of ABS material. It is used as a disposable item to collect patient�