INTRAVIA 2B8013
GUDID 20085412035264
INTRAVIA Container, 500 mL Capacity
BAXTER INTERNATIONAL INC.
Intravenous administration bag/bottle| Primary Device ID | 20085412035264 |
| NIH Device Record Key | 0c44865f-c991-4b64-962f-ec87d11d85f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTRAVIA |
| Version Model Number | 2B8013 |
| Catalog Number | 2B8013 |
| Company DUNS | 005146311 |
| Company Name | BAXTER INTERNATIONAL 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com | |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
| Special Storage Condition, Specify | Between 0 and 0 *Adhere to storage requirements of added medication. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412035260 [Primary] |
| GS1 | 20085412035264 [Package] Contains: 00085412035260 Package: PACK [6 Units] In Commercial Distribution |
| GS1 | 50085412035265 [Package] Package: CASE [48 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K964853
FDA Product Code
| KPE | CONTAINER, I.V. |
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 | 2019-10-23 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [INTRAVIA]
| 20085412035264 | INTRAVIA Container, 500 mL Capacity |
| 20085412029577 | INTRAVIA Container, 250 mL Capacity |
| 20085412029560 | INTRAVIA Container, 500 mL Capacity |
| 50085412003509 | INTRAVIA Container, 50 mL Capacity |
| 50085412003462 | INTRAVIA Container, 150 mL Capacity |
| 20085412003195 | INTRAVIA Container, 250 mL Capacity |
| 20085412000040 | INTRAVIA Container, 1000 mL Capacity |
Trademark Results [INTRAVIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTRAVIA 74695029 2144957 Live/Registered |
Baxter International Inc. 1995-06-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.