FDA UDI
In Commercial Distribution
🇺🇸 United States
Quantum
DI: 05060434423979
·
Model: LSC_HRC70
·
SPECTRUM MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Quantum
- Primary DI
- 05060434423979
- Version / Model
- LSC_HRC70
- Catalog Number
- LSC_HRC70
- Company Name
- SPECTRUM MEDICAL LIMITED
- Labeler DUNS
- 516398679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-12-22
- Public Version
- 1
- Public Version Date
- 2024-01-01
- Public Version Status
- New
- Public Device Record Key
- 86e9054e-d517-43b5-8033-419dfbe3a856
Device Description
Quantum Reservoir Level Sensor Cradle - R70.5
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KRI | Accessory Equipment, Cardiopulmonary Bypass | Cardiovascular | 870.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62743 | Sensor holder, single-use | A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 25060434423973 | GS1 | ||||
| Primary | 05060434423979 | GS1 |
Customer Contacts
- Phone
- +441242650120
- [email protected]
- Phone
- 8002652331
- [email protected]
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 76 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius