FDA UDI
In Commercial Distribution
🇺🇸 United States
Blood Collection Monitor CM350
DI: 08809241446224
·
Model: CM350
·
CENTRON CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Blood Collection Monitor CM350
- Primary DI
- 08809241446224
- Version / Model
- CM350
- Catalog Number
- CM350
- Company Name
- CENTRON CORPORATION
- Labeler DUNS
- 557821760
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-17
- Public Version
- 1
- Public Version Date
- 2020-04-27
- Public Version Status
- New
- Public Device Record Key
- 21072e4e-394f-408b-bc1d-5a0de9fd7b97
Device Description
The Blood Collection Monitor CM350 is a blood collection device to measure blood volume collected in the blood bag, and clamps the tubing automatically when the collected blood volume reaches the preset target volume. The device is powered by a rechargeable battery.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KSQ | Device, Blood Mixing And Blood Weighing | Hematology | 864.9195 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36405 | Blood donation rocker | A mains electricity (AC-powered), electromechanical device intended to maintain blood homogeneity through a continuous rocking motion. It is mostly used in a blood donor unit, department, or mobile unit, where the blood is kept in motion as it is drawn from the blood donor and runs into a blood donor bag or a set of collection tubes which lie in a cradle-like holder attached to this device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809241446224 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1.4 | Kilogram | |
| Width | 16.2 | Centimeter | |
| Height | 12.0 | Centimeter | |
| Depth | 6.0 | Centimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity