BiCart 109733
GUDID 37332414088317
Sodium Bicarbonate for Hemodialysis
GAMBRO AB
Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate Haemodialysis concentrate 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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