CELSITE 5433556
GUDID 04046963594916
CELSITE ST305H SM SET PUR 8,5F IV USA
B BRAUN INTERVENTIONAL SYSTEMS, INC
Vascular port/catheter| Primary Device ID | 04046963594916 |
| NIH Device Record Key | e2b30c82-a024-48ff-8b07-e65fb572dade |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CELSITE |
| Version Model Number | 5433556 |
| Catalog Number | 5433556 |
| Company DUNS | 784259751 |
| Company Name | B BRAUN INTERVENTIONAL SYSTEMS, INC |
| 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 | true |
| 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
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 8.5 French |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT. |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AVOID FREEZE & HEAT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046963594916 [Primary] |
FDA Product Code
| LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, 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 | 4 |
| Public Version Date | 2021-06-21 |
| Device Publish Date | 2015-07-29 |
On-Brand Devices [CELSITE]
| 04046963595036 | CELSITE ST305P SM SET PUR 6,5F IV USA |
| 04046963595012 | CELSITE ST315 SM SET SIL 6,5F IV USA |
| 04046963595005 | CELSITE ST311F ST SET SIL 6,5F IV USA |
| 04046963594992 | CELSITE ST311 ST SET SIL 8,5F IV USA |
| 04046963594985 | CELSITE BABYPORT S SET SIL 6F IV USA |
| 04046963594978 | CELSITE ST301G ST SET SIL 10F IV USA |
| 04046963594954 | CELSITE ST305 SM SET SIL 6,5F IV USA |
| 04046963594947 | CELSITE BABYPORT SET PUR 4,5F IV USA |
| 04046963594930 | CELSITE BRACHIAL SET PUR 5F IV USA |
| 04046963594916 | CELSITE ST305H SM SET PUR 8,5F IV USA |
| 04046963594893 | CELSITE ST301H ST SET PUR 8,5F IV USA |
| 04046963594817 | CELSITE ST301 ST SET SIL 8,5F IV USA |
| 04046963594732 | CELSITE ST405L SM SET SIL 10F IV USA |
| 04046963594725 | CELSITE ST401L ST SET SIL 10F IV USA |
| 04046963594718 | CELSITE ST305V SM SET SIL 7,5F USA |
| 04046963595135 | CELSITE ST505H SM SET PUR8.5F IV USA |
| 04046963595111 | CELSITE ST501H ST SET PUR8.5F IV USA |
| 04046963595104 | CELSITE ST501G ST SET SIL 10F IV USA |
| 04046963594763 | CELSITE STL205F SM SET SIL 6,5F L IV USA |
| 04046963594756 | CELSITE STR201L ST SET SIL 8,5F R IV USA |
Trademark Results [CELSITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELSITE 74087611 1682795 Live/Registered |
B. BRAUN MEDICAL S.A. 1990-08-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.