CIV CIV-033

GUDID 00817708020069

Fluid Delivery Set

EMED TECHNOLOGIES CORPORATION

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• Primary Device ID: 00817708020069
• NIH Device Record Key: 66494969-7822-45a1-953b-49cda761ef5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CIV
• Version Model Number: CIV-033
• Catalog Number: CIV-033
• Company DUNS: 622637544
• Company Name: EMED TECHNOLOGIES CORPORATION
• Device Count: 100
• 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

Customer Support Contacts

• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817708020052 [Unit of Use]
GS1	00817708020069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935642

FDA Product Code

• FPK: Tubing, Fluid Delivery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-23

On-Brand Devices [CIV]

• 00817708020106: Fluid Delivery Set
• 00817708020083: Fluid Delivery Set
• 00817708020069: Fluid Delivery Set
• 00817708020045: Fluid Delivery Set
• 00817708020021: Fluid Delivery Set