CARPEDIEM
GUDID 08051736007476
CARPEDIEM
Mozarc Medical US LLC
Haemodialysis system, institutional| Primary Device ID | 08051736007476 |
| NIH Device Record Key | 74ea56f1-1c24-44b5-a7be-880d9567e159 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CARPEDIEM |
| Version Model Number | IB7010250 |
| Company DUNS | 118997146 |
| Company Name | Mozarc Medical US LLC |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com | |
| Phone | +39053529111 |
| RegulatoryOperations@mozarcmedical.com |
Device Dimensions
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
| Length | 118 Centimeter |
| Width | 57 Centimeter |
| Height | 67 Centimeter |
| Weight | 40 Gram |
Operating and Storage Conditions
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08051736007476 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN180055
FDA Product Code
| QIR | Pediatric Hemodialysis System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-19 |
| Device Publish Date | 2025-05-09 |
Devices Manufactured by Mozarc Medical US LLC
| 10884521811102 - Ritus | 2025-12-05 Peritoneal Dialysis Accessory,Medical Grade Silicone Adhesive, Type A |
| 20884521811116 - Ritus | 2025-12-05 Dialysis Catheter Accessory,Introducer Needle,18 G (1.27 mm) x 7 cm |
| 20884521811123 - Ritus | 2025-12-05 Dialysis Catheter Accessory,J/Straight Stainless Steel Guidewire,0.038"" x 27.7"" (0.965 mm x 70 cm) |
| 10884521811188 - Ritus | 2025-12-05 Dialysis Catheter Accessory,Dilator,10 Fr/Ch (3.3 mm), 15 cm |
| 20884521811192 - Ritus | 2025-12-05 Dialysis Catheter Accessory,J/Straight Stainless Steel Guidewire,0.035"" x 27.7"" (0.889 mm x 70 cm) |
| 10884521852631 - Ritus | 2025-12-05 Pediatric Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs |
| 10884521852648 - Ritus | 2025-12-05 Pediatric Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs |
| 10884521852686 - Ritus | 2025-12-05 Pediatric Peritoneal Dialysis Catheter, Tenckhoff, 1 Subcutaneous Cuff |
Trademark Results [CARPEDIEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARPEDIEM 97352103 not registered Live/Pending |
ORBEA, S. COOP. 2022-04-07 |
 CARPEDIEM 88110810 not registered Live/Pending |
BELLCO S.r.l. 2018-09-10 |
 CARPEDIEM 86686652 4901311 Live/Registered |
Carpe Diem Worldwide 2015-07-08 |
 CARPEDIEM 74126291 not registered Dead/Abandoned |
NRS Partners, Inc. 1990-12-24 |
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