| Primary Device ID | 37332414121595 |
| NIH Device Record Key | fad40665-b136-4701-97b5-e135fbdca46f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NA - NA |
| Version Model Number | 115959 |
| Catalog Number | 115959 |
| Company DUNS | 428788780 |
| Company Name | GAMBRO DASCO SPA |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 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 |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Total Volume | 5 Liter |
| Special Storage Condition, Specify | Between 0 and 0 *The accessories for hemodialysis must be stored in a dry place, between 0°C (32°F) and 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *The accessories for hemodialysis must be stored in a dry place, between 0°C (32°F) and 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *The accessories for hemodialysis must be stored in a dry place, between 0°C (32°F) and 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *The accessories for hemodialysis must be stored in a dry place, between 0°C (32°F) and 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *The accessories for hemodialysis must be stored in a dry place, between 0°C (32°F) and 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *The accessories for hemodialysis must be stored in a dry place, between 0°C (32°F) and 30°C (86°F) |
| Special Storage Condition, Specify | Between 0 and 0 *The accessories for hemodialysis must be stored in a dry place, between 0°C (32°F) and 30°C (86°F) |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414121594 [Primary] |
| GS1 | 37332414121595 [Package] Contains: 07332414121594 Package: CASE [40 Units] In Commercial Distribution |
| MON | SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-07 |
| Device Publish Date | 2025-01-30 |
| 37332414121595 - NA - NA | 2025-02-07Accessory Drain Bag (5L); Accessory for hemodialysis |
| 37332414121595 - NA - NA | 2025-02-07 Accessory Drain Bag (5L); Accessory for hemodialysis |
| 37332414075829 - NA | 2021-08-09 SP 418 (9L Bag) Accessory Drain Bag |
| 37332414004690 - NA | 2019-06-07 S-660-C Accessory Y connector |
| 37332414010868 - NA | 2019-06-07 SP-C13 Accessory spike |
| 37332414032532 - NA | 2019-06-07 SP-394 Accessory reinfusion line |
| 37332414044733 - NA | 2019-06-07 SP-390 Accessory adaptor |
| 37332414048915 - NA | 2019-06-07 GMB-SP127 Accessory Y connector |
| 37332414075430 - NA | 2019-06-07 SP-420 Accessory extension line |