OPTFlow OPT12604-Q10

GUDID 00817708021950

OPTFlow SUB-Q 1 Needle set, 26ga RW x 4mm, 70cm Tubing with safety mechanism, Box of 10

EMED TECHNOLOGIES CORPORATION

Mechanical infusion pump administration set

• Primary Device ID: 00817708021950
• NIH Device Record Key: 9f1e94f8-0084-4ef2-9b79-51cb81a679db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTFlow
• Version Model Number: OPT12604-Q10
• Catalog Number: OPT12604-Q10
• Company DUNS: 622637544
• Company Name: EMED TECHNOLOGIES CORPORATION
• Device Count: 10
• 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

Device Dimensions

• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter
• Device Size Text, specify: 0
• Needle Gauge: 26 Gauge
• Length: 4 Millimeter
• Length: 70 Centimeter
• Total Volume: 0.28 Milliliter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817708021950 [Unit of Use]
GS1	10817708021957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140131

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2020-12-15
• Device Publish Date: 2020-12-07

On-Brand Devices [OPTFlow]

• 00817708022032: OPTFlow SUB-Q 1 Needle set, 26ga RW x 14mm, 70cm Tubing with safety mechanism, Box of 10
• 00817708022018: OPTFlow SUB-Q 1 Needle set, 26ga RW x 12mm, 70cm Tubing with safety mechanism, Box of 10
• 00817708021998: OPTFlow SUB-Q 1 Needle set, 26ga RW x 9mm, 70cm Tubing with safety mechanism, Box of 10
• 00817708021974: OPTFlow SUB-Q 1 Needle set, 26ga RW x 6mm, 70cm Tubing with safety mechanism, Box of 10
• 00817708021950: OPTFlow SUB-Q 1 Needle set, 26ga RW x 4mm, 70cm Tubing with safety mechanism, Box of 10