FDA UDI
In Commercial Distribution
🇺🇸 United States
MARS TREATMENT KIT TYPE 1116/1 - X-MARS US
DI: 37332414107728
·
Model: 800541
·
GAMBRO AB
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MARS TREATMENT KIT TYPE 1116/1 - X-MARS US
- Primary DI
- 37332414107728
- Version / Model
- 800541
- Catalog Number
- 800541
- Company Name
- GAMBRO AB
- Labeler DUNS
- 354021099
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-26
- Public Version
- 7
- Public Version Date
- 2023-08-10
- Public Version Status
- Update
- Public Device Record Key
- e1a492a7-ec05-46d4-8bd0-edd1f9f54f59
Device Description
The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with the Prismaflex device (produced by Gambro Lundia AB) for MARS therapy.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLD | Apparatus, Hemoperfusion, Sorbent | Gastroenterology, Urology | 876.5870 | 2 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | 876.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46212 | Bound solute dialysis system component set | A collection of devices that typically include filters, tubing, and connectors used in a bound solute dialysis system for the removal of albumin-bound toxins (e.g., bile acids, bilirubin, heavy metals, phenols) from a patient's blood during extracorporeal blood purification, typically in persons suffering liver failure or poisoning/drug overdose. The items in this set are devices that function in association with a system pump/monitor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 37332414107728 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133807 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39.2 – 86 Degrees Fahrenheit