BiCart 109733
GUDID 37332414088317
Sodium Bicarbonate for Hemodialysis
GAMBRO AB
Haemodialysis concentrate| Primary Device ID | 37332414088317 |
| NIH Device Record Key | 188c069a-0101-4c79-9297-dad36840e2fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiCart |
| Version Model Number | 720 |
| Catalog Number | 109733 |
| Company DUNS | 354021099 |
| Company Name | GAMBRO AB |
| 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 | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
| Weight | 720 Gram |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414088316 [Primary] |
| GS1 | 37332414088317 [Package] Contains: 07332414088316 Package: CASE [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013724
FDA Product Code
| KPO | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [BiCart]
| 37332414110575 | Sodium Bicarbonate for Hemodialysis |
| 37332414088317 | Sodium Bicarbonate for Hemodialysis |
Trademark Results [BiCart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BICART 73700108 1538839 Live/Registered |
GAMBRO AB 1987-12-10 |
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