3 L NON STERILE WASTE BAGS

GUDID 38051736003769

3 L NON STERILE WASTE BAGS

BELLCO SRL

Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner Suction system canister liner

• Primary Device ID: 38051736003769
• NIH Device Record Key: b2ab957e-f860-4688-8ca5-8324c6c14058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3 L NON STERILE WASTE BAGS
• Version Model Number: IB0507009
• Company DUNS: 338685723
• Company Name: BELLCO SRL
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 364 Millimeter
• Width: 210 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08051736003768 [Primary]
GS1	10884521816732 [Unit of Use]
GS1	38051736003769 [Package]; Contains: 08051736003768; Package: CASE [20 Units]; In Commercial Distribution

FDA Product Code

• BTC: BAG, RESERVOIR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-12
• Device Publish Date: 2021-05-30

Devices Manufactured by BELLCO SRL

• 68051736007041 - CLEARUM HS: 2023-08-14 CLEARUM HS 17 High Flux dialyzer
• 08051736003652 - CARPEDIEM: 2023-07-14 CARPEDIEM
• 38051736003769 - 3 L NON STERILE WASTE BAGS: 2023-07-123 L NON STERILE WASTE BAGS
• 38051736003769 - 3 L NON STERILE WASTE BAGS: 2023-07-12 3 L NON STERILE WASTE BAGS
• 38032979792290 - CARPEDIEM: 2022-02-09 BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 025 FOR CARPEDIEM
• 38032979792283 - CARPEDIEM: 2022-01-31 BL 250 HEMOFILTRATION/HEMODIALYSIS KIT 015 FOR CARPEDIEM
• 68051736004132 - CLEARUM HS: 2021-01-11 CLEARUM HS 13 High Flux dialyzer
• 68051736004149 - CLEARUM HS: 2021-01-11 CLEARUM HS 15 High Flux dialyzer
• 68051736004156 - CLEARUM HS: 2021-01-11 CLEARUM HS 17 High Flux dialyzer