FDA UDI
In Commercial Distribution
🇺🇸 United States
Crit-Line®
DI: 00840861101122
·
Model: CL10051001
·
Fresenius Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Crit-Line®
- Primary DI
- 00840861101122
- Version / Model
- CL10051001
- Company Name
- Fresenius Usa, Inc.
- Labeler DUNS
- 076594100
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-17
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a5bfa337-76f7-4a5d-a0ee-d6b50aa35ac2
Device Description
Blood Volume Monitor
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOC | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37218 | Haemodialysis system blood volume monitor | A mains electricity (AC-powered) device designed to non-invasively monitor the relative variations of the blood volume during a haemodialysis treatment. The blood is lead through a chamber in this device where measurements are taken and calculations of haematocrit (volume percent of erythrocytes), haemoglobin oxygen saturation (SpO2), and percent change in blood volume are made and displayed. In addition the monitor may estimate and display the urea reduction ration (URR) on relative changes in urea nitrogen concentration in the spent dialysate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840861101122 | GS1 |
Customer Contacts
- Phone
- +1(801)451-9000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141997 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 51 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 125 Degrees Fahrenheit