ALL-IN-ONE 2B8124
GUDID 50085412042126
ALL-IN-ONE Container, Empty EVA Container with Three Lead Transfer Set, 2000 mL Capacity
BAXTER INTERNATIONAL INC.
Intravenous administration bag/bottle| Primary Device ID | 50085412042126 |
| NIH Device Record Key | c5c0b544-a78a-4c7e-a732-79a6c461c0f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALL-IN-ONE |
| Version Model Number | 2B8124 |
| Catalog Number | 2B8124 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412042121 [Primary] |
| GS1 | 50085412042126 [Package] Contains: 00085412042121 Package: CASE [15 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090096
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 [ALL-IN-ONE]
| 50085412043864 | ALL-IN-ONE Container, Empty EVA Container with Three Lead Transfer Set, 1000 mL Capacity |
| 50085412042126 | ALL-IN-ONE Container, Empty EVA Container with Three Lead Transfer Set, 2000 mL Capacity |
| 50085412041419 | ALL-IN-ONE Container, Empty EVA Container with Three Lead Transfer Set, 3000 mL Capacity |
Trademark Results [ALL-IN-ONE]
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