extriCARE

GUDID 20879766005659

NPWT Bandage-Extra large oval with tubing set

OAKWELL DISTRIBUTION, INC.

Multi-purpose low-vacuum suction system

• Primary Device ID: 20879766005659
• NIH Device Record Key: fa5d64e5-09c5-4510-8a3f-88ddb1a98a31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: extriCARE
• Version Model Number: EC2400-IM
• Company DUNS: 033337813
• Company Name: OAKWELL DISTRIBUTION, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00879766005655 [Primary]
GS1	20879766005659 [Package]; Contains: 00879766005655; Package: Case [45 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110078

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-30

On-Brand Devices [extriCARE]

• 10879766005843: 1 piece of Extra Skin Film
• 10879766005836: NPWT Foam kit-samll
• 10879766005829: NPWT Foam kit-large
• 20879766005796: 7 pieces of silicone gel strip
• 20879766005772: NPWT Bandage-Incision management with tubing set
• 20879766005765: Mini oval bandage with tubing set
• 20879766005758: NPWT Bandage-foot with tubing set
• 20879766005741: NPWT Bandage-Sacrum with tubing set
• 20879766005734: extriCARE Small oval dressing
• 20879766005727: extriCARE large oval dressing
• 10879766005713: UK type snap-on plug for EC2400 adapter
• 10879766005690: EC 2400 adapter with UK
• 10879766005676: NPWT Foam kit-Small
• 10879766005669: NPWT Foam kit-Large
• 20879766005659: NPWT Bandage-Extra large oval with tubing set
• 20879766005642: NPWT Bandage-Mini oval with tubing set
• 20879766005635: NPWT Bandage-Foot with tubing set
• 20879766005628: NPWT Bandage- Sacrum with tubing set
• 20879766005611: NPWT Bandage-Small oval tubing set
• 20879766005604: NPWT Bandage-Large oval tubing set
• 10879766005584: EC2400 adaper with US
• 10879766005577: EC2400 adapter without the snap-on plug
• 10879766005560: Designed to fit the extriCARE3600 device with a 1000cc canister
• 10879766005553: Designed to fit the extriCARE 3600 device with a 400cc canister
• 10879766005549: Designed to fit the extriCARE 2400 device with a 400cc canister
• 10879766005539: Designed to fit the extriCARE 2400 device with a 100cc canister
• 20879766005529: 3600 1000cc Canister
• 20879766005512: 3600 400cc Canister
• 20879766005505: 2400 400cc Canister
• 20879766005499: 2400 100CC Canister
• 10879766005478: 3600 Pump set with one canister in a box
• 10879766005461: 2400 Pump set with a canister in a box