| Primary Device ID | 04046964295843 |
| NIH Device Record Key | bfc14946-cec5-4c84-a9e0-83f3a437d12e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prontosan® |
| Version Model Number | 400443 |
| Catalog Number | 400443 |
| Company DUNS | 002397347 |
| Company Name | B. BRAUN MEDICAL INC. |
| 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 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE OR FREEZE. |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT. |
| Special Storage Condition, Specify | Between 0 and 0 *STORE AT ROOM TEMPERATURE. |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *AVOID EXCESSIVE HEAT |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temp |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT REFRIGERATE |
| Special Storage Condition, Specify | Between 0 and 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964295836 [Unit of Use] |
| GS1 | 04046964295843 [Primary] |
| FRO | Dressing, wound, drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-05-19 |
| Device Publish Date | 2016-09-23 |
| 04046964295881 | Prontosan® Wound Gel, 30 mL Bottl e |
| 04046964295782 | Prontosan® Wound Irrigation Solut ion, 350 mL Bottle |
| 04046964295744 | Prontosan® Wound Irrigation Solut ion, 40 mL Ampule |
| 07612449140426 | PRONTOSAN WOUND IRRIGATION CAP "USA" |
| 04046964295843 | PRONTOSAN WOUND IRRIGATION SOLUT. 1000ML |
| 04046964678233 | Prontosan® Wound Gel X, 250g Tube |
| 04046955726479 | PRONTOSAN SOLUTION RF "US" 350ML-STERIL |
| 04046955651092 | Prontosan® Wound Irrigation Solution, 1000 mL Bottle |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PRONTOSAN 77349334 3652026 Live/Registered |
B. Braun Medical Inc. 2007-12-11 |