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

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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