SURFLO
GUDID 54806017510195
SURFLO IV Catheter
TERUMO (PHILIPPINES) CORPORATION
Peripheral vascular catheter| Primary Device ID | 54806017510195 |
| NIH Device Record Key | 7e0d2e9e-2d83-4b9f-bab5-85b4882931e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURFLO |
| Version Model Number | SR-OX1864CA |
| Company DUNS | 718848773 |
| Company Name | TERUMO (PHILIPPINES) CORPORATION |
| Device Count | 50 |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 2.5 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
| Special Storage Condition, Specify | Between 0 and 0 *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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14806017510197 [Unit of Use] |
| GS1 | 34806017510191 [Primary] |
| GS1 | 54806017510195 [Package] Contains: 34806017510191 Package: Inner Carton [4 Units] In Commercial Distribution |
| GS1 | 74806017510199 [Package] Package: Outer Carton [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133280
FDA Product Code
| FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days |
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 | 2016-09-14 |
On-Brand Devices [SURFLO]
| 54806017512281 | SURFLO IV Catheter |
| 74806017512278 | SURFLO IV Catheter |
| 54806017512267 | SURFLO IV Catheter |
| 54806017512250 | SURFLO IV Catheter |
| 74806017512247 | SURFLO IV Catheter |
| 54806017512236 | SURFLO IV Catheter |
| 54806017512229 | SURFLO IV Catheter |
| 54806017510195 | SURFLO IV Catheter |
| 74806017510182 | SURFLO IV Catheter |
| 54806017510171 | SURFLO IV Catheter |
| 74806017510168 | SURFLO IV Catheter |
| 74806017510151 | SURFLO IV Catheter |
| 74806017510144 | SURFLO IV Catheter |
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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