Exadoral® 4608660-02
GUDID 04046955861170
EXADORAL 5 ML 2-PART PURPLE PLU. STR. US
B. BRAUN MEDICAL INC.
Oral liquid dose dispenser cabinet| Primary Device ID | 04046955861170 |
| NIH Device Record Key | 5b4a5280-879a-4c01-95c5-05bb35143e7c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exadoral® |
| Version Model Number | 4608660-02 |
| Catalog Number | 4608660-02 |
| Company DUNS | 002397347 |
| Company Name | B. BRAUN MEDICAL INC. |
| Device Count | 100 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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)227-2862 |
| BBMUS_Service.EmailOrders@bbraun.com | |
| Phone | +1(800)227-2862 |
| BBMUS_Service.EmailOrders@bbraun.com | |
| Phone | +1(800)227-2862 |
| BBMUS_Service.EmailOrders@bbraun.com | |
| Phone | +1(800)227-2862 |
| BBMUS_Service.EmailOrders@bbraun.com | |
| Phone | +1(800)227-2862 |
| BBMUS_Service.EmailOrders@bbraun.com | |
| Phone | +1(800)227-2862 |
| BBMUS_Service.EmailOrders@bbraun.com | |
| Phone | +1(800)227-2862 |
| BBMUS_Service.EmailOrders@bbraun.com | |
| Phone | +1(800)227-2862 |
| BBMUS_Service.EmailOrders@bbraun.com | |
| Phone | +1(800)227-2862 |
| BBMUS_Service.EmailOrders@bbraun.com | |
| Phone | +1(800)227-2862 |
| BBMUS_Service.EmailOrders@bbraun.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046955861156 [Unit of Use] |
| GS1 | 04046955861163 [Primary] |
| GS1 | 04046955861170 [Package] Contains: 04046955861163 Package: Carton [20 Units] In Commercial Distribution |
FDA Product Code
| KYX | DISPENSER, LIQUID MEDICATION |
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 | 2025-09-16 |
| Device Publish Date | 2025-09-08 |
On-Brand Devices [Exadoral®]
| 04046964723759 | Exadoral® Oral Syringe |
| 04046955861217 | EXADORAL 10 ML 2-PART PURPLE PLU. STR.US |
| 04046955861170 | EXADORAL 5 ML 2-PART PURPLE PLU. STR. US |
| 04046955861132 | EXADORAL 2 ML 2-PART PURPLE PLU. STR. US |
Trademark Results [Exadoral]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXADORAL 79042409 3524347 Dead/Cancelled |
B. Braun Melsungen Aktiengesellschaft 2007-07-09 |
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