SUB-Q OPT62609U
GUDID 00817708023299
OPTFlow SUB-Q 6 Needle set, 26ga TW x 9mm, 70cm Tubing with safety mechanism
EMED TECHNOLOGIES CORPORATION
Mechanical infusion pump administration set| Primary Device ID | 00817708023299 |
| NIH Device Record Key | 1a593ac1-af8e-4ed1-87a7-51761fe9d2b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUB-Q |
| Version Model Number | FP-0010096 |
| Catalog Number | OPT62609U |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
| Device Size Text, specify | 0 |
| Needle Gauge | 26 Gauge |
| Length | 9 Millimeter |
| Length | 70 Centimeter |
| Total Volume | 1.47 Milliliter |
Operating and Storage Conditions
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between -5 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817708023299 [Primary] |
| GS1 | 00817708023305 [Unit of Use] |
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 | 2019-03-04 |
| Device Publish Date | 2019-01-30 |
On-Brand Devices [SUB-Q]
| 00081770802254 | OPTFlow SUB-Q 2 Needle set, 24ga TW x 6mm, 70cm Tubing |
| 00817708022919 | OPT12909, OPTFlow SUB-Q 1 Needle set, 29ga RW x 9mm, 70cm Tubing |
| 00817708022896 | Subcutaneous Tissue Infusion Set |
| 00817708022889 | SAF-Q-206-G24-70 |
| 00817708022865 | SAF-Q-112-G24-12 |
| 00817708022841 | OPTFlow SUB-Q 6 Needle set, 24ga TW x 12mm, 70cm Tubing |
| 00817708022827 | OPTFlow SUB-Q 6 Needle set, 24ga TW x 9mm, 70cm Tubing |
| 00817708022803 | OPTFlow SUB-Q 5 Needle set, 24ga TW x 12mm, 70cm Tubing |
| 00817708022780 | OPTFlow SUB-Q 5 Needle set, 24ga TW x 9mm, 70cm Tubing |
| 00817708022766 | OPTFlow SUB-Q 4 Needle set, 24ga TW x 14mm, 70cm Tubing |
| 00817708022742 | OPTFlow SUB-Q 4 Needle set, 24ga TW x 12mm, 70cm Tubing |
| 00817708022728 | OPTFlow SUB-Q 4 Needle set, 24ga TW x 9mm, 70cm Tubing |
| 00817708022704 | OPTFlow SUB-Q 4 Needle set, 24ga TW x 6mm, 70cm Tubing |
| 00817708022681 | OPTFlow SUB-Q 3 Needle set, 24ga TW x 14mm, 70cm Tubing |
| 00817708022667 | OPTFlow SUB-Q 3 Needle set, 24ga TW x 12mm, 70cm Tubing |
| 00817708022643 | OPTFlow SUB-Q 3 Needle set, 24ga TW x 9mm, 70cm Tubing |
| 00817708022629 | OPTFlow SUB-Q 3 Needle set, 24ga TW x 6mm, 70cm Tubing |
| 00817708022605 | OPTFlow SUB-Q 2 Needle set, 24ga TW x 14mm, 70cm Tubing |
| 00817708022582 | OPTFlow SUB-Q Needle set, 24ga TW x 12mm, 70mm Tubing |
| 00817708022568 | OPTFlow SUB-Q 2 Needle set, 24ga TW x 9mm, 70cm Tubing |
| 00817708022520 | OPTFlow SUB-Q 2 Needle set, 24ga TW x 4mm, 70cm Tubing |
| 00817708022506 | OPTFlow SUB-Q 1 Needle set, 24ga TW x 14mm, 70cm Tubing |
| 00817708022483 | OPTFlow SUB-Q 1 Needle set, 24ga TW x 12mm, 70cm Tubing |
| 00817708022469 | OPTFlow SUB-Q 1 Needle set, 24ga TW x 9mm, 70cm Tubing |
| 00817708022445 | OPTFlow SUB-Q 1 Needle set, 24ga TW x 6mm, 70cm Tubing |
| 00817708022421 | OPTFlow SUB-Q 1 Needle set, 24ga TW x 4mm, 70cm Tubing |
| 00817708022407 | OPTFlow SUB-Q 6 Needle set, 26ga RW x 12mm, 70cm Tubing |
| 00817708022384 | OPTFlow SUB-Q 6 Needle set, 26ga RW x 9mm, 70cm Tubing |
| 00817708022360 | OPTFlow SUB-Q 5 Needle set, 26ga RW x 12mm, 70cm Tubing |
| 00817708022346 | OPTFlow SUB-Q 5 Needle set, 26ga RW x 9mm, 70cm Tubing |
| 00817708022322 | OPTFlow SUB-Q 5 Needle set, 26ga RW x 6mm, 70cm Tubing |
| 00817708022308 | OPTFlow SUB-Q 4 Needle set, 26ga RW x 14mm, 70cm Tubing |
| 00817708022285 | OPTFlow SUB-Q 4 Needle set, 26ga RW x 12mm, 70cm Tubing |
| 00817708022261 | OPTFlow SUB-Q 4 Needle set, 26ga RW x 9mm, 70cm Tubing |
| 00817708022247 | OPTFlow SUB-Q 4 Needle set, 26ga RW x 6mm, 70cm Tubing |
| 00817708022223 | OPTFlow SUB-Q 3 Needle set, 26ga x 14mm, 70cm Tubing |
| 00817708022209 | OTPFlow SUB-Q 3 Needle set, 26ga x 12mm, 70cm Tubing |
| 00817708022186 | OPTFlow SUB-Q 3 Needle set, 26ga RW x 9mm, 70cm Tubing |
| 00817708022162 | OPTFlow SUB-Q 3 Needle set, 26ga RW x 6mm, 70cm Tubing |
| 00817708022148 | OPTFlow SUB-Q 2 Needle set, 26ga RW x 14mm, 70cm Tubing |
| 00817708022124 | OPTFlow SUB-Q 2 Needle set, 26ga RW x 12mm, 70cm Tubing |
| 00817708022100 | OPTFlow SUB-Q 2 Needle set, 26ga RW x 9mm, 70cm Tubing |
| 00817708022087 | OPTFlow SUB-Q 2 Needle set, 26ga RW x 6mm, 70cm Tubing |
| 00817708022063 | OPTFlow SUB-Q 2 Needle set, 26ga RW x 4mm, 70cm Tubing |
| 00817708022049 | OPTFlow SUB-Q 1 Needle set, 26ga RW x 14mm, 70cm Tubing |
| 00817708022025 | OPTFlow SUB-Q 1 Needle set, 26ga RW x 12mm, 70cm Tubing |
| 00817708022001 | OPTFlow SUB-Q 1 Needle set, 26ga RW x 9mm, 70cm Tubing |
| 00817708021981 | OPTFlow SUB-Q 1 Needle set, 26ga RW x 6mm, 70cm Tubing |
| 00817708021967 | OPTFlow SUB-Q 1 Needle set, 26ga RW x 4mm, 70cm Tubing |
| 00817708021882 | Subcutaneous Tissue Infusion Set |
Trademark Results [SUB-Q]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUB-Q 86680049 not registered Dead/Abandoned |
Hoke Media, LLC 2015-07-01 |
 SUB-Q 78898673 not registered Dead/Abandoned |
Medical Research Institute, Inc. 2006-06-01 |
 SUB-Q 75631282 2513094 Dead/Cancelled |
Sub-Q, Inc. 1999-02-01 |
 SUB-Q 75622718 2513082 Dead/Cancelled |
Sub-Q, Inc. 1999-01-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.