SURFLO® SV-S23FL35
GUDID 55413206054928
SURFLO® WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION
Terumo Europe NV
Scalp vein intravenous administration set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set Venous butterfly needle/set| Primary Device ID | 55413206054928 |
| NIH Device Record Key | 5c4592a6-8ca0-4823-aebe-bc786c5013cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURFLO® |
| Version Model Number | SV-S23FL35 |
| Catalog Number | SV-S23FL35 |
| Company DUNS | 370193559 |
| Company Name | Terumo Europe NV |
| Device Count | 1 |
| 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 |
Customer Support Contacts
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedica | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Needle Gauge | 23 Gauge |
| Pore Size | 20 Micrometer |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity. Fragile. Handle with Care. Keep dry. Keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05413206054923 [Primary] |
| GS1 | 35413206054924 [Package] Contains: 05413206054923 Package: Shelfbox [100 Units] In Commercial Distribution |
| GS1 | 55413206054928 [Package] Contains: 35413206054924 Package: Carton [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133894
FDA Product Code
| FPA | Set, Administration, Intravascular |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-05 |
On-Brand Devices [SURFLO®]
| 55413206214919 | SURFLO® WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION |
| 55413206055918 | SURFLO® WINGED INFUSION SET WITH NEEDLE PROTECTION |
| 55413206055901 | SURFLO® WINGED INFUSION SET WITH NEEDLE PROTECTION |
| 55413206054942 | SURFLO® WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION |
| 55413206054928 | SURFLO® WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION |
| 55413206054904 | SURFLO® WINGED INFUSION SET WITH NEEDLE PROTECTION |
| 55413206054881 | SURFLO® WINGED INFUSION SET WITH NEEDLE PROTECTION |
| 35413206246206 | SURFLO® WINGED INFUSION SET WITH NEEDLE PROTECTION |
Trademark Results [SURFLO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURFLO 98020905 not registered Live/Pending |
ChampionX USA Inc. 2023-05-31 |
 SURFLO 79256772 5911338 Live/Registered |
surflo Co., Ltd. 2019-03-05 |
 SURFLO 74019926 not registered Dead/Abandoned |
Continental Industries, Inc. 1990-01-17 |
 SURFLO 73141306 1154325 Dead/Cancelled |
N L INDUSTRIES, INC. 1977-09-15 |
 SURFLO 73034902 1028554 Live/Registered |
KABUSHIKI KAISHA JINTAN TERUMO 1974-10-18 |
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