Disposable Circuit

GUDID 10709078012294

Circuit, Disposable, 15mm, Non Heated, Dual Limb (20 pack)

WESTMED, INC.

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• Primary Device ID: 10709078012294
• NIH Device Record Key: 3e458e0a-e83c-419b-b8ba-5c51d77efc94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Circuit
• Version Model Number: 8306
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• Device Count: 20
• 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: false
• 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	00709078012280 [Primary]
GS1	10709078012294 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922492

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Disposable Circuit]

• 10709078008679: Circuit, Disposable, 22mm, Non-Heated Dual Limb w/ BV filter
• 10709078012294: Circuit, Disposable, 15mm, Non Heated, Dual Limb (20 pack)
• 10709078008860: Circuit, Disposable, 15mm, Non Heated, Dual Limb, B/V Filters