FDA UDI
In Commercial Distribution
🇺🇸 United States
Nonin
DI: 00833166007558
·
Model: 7500PS
·
NONIN MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Nonin
- Primary DI
- 00833166007558
- Version / Model
- 7500PS
- Company Name
- NONIN MEDICAL, INC.
- Labeler DUNS
- 174959692
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-14
- Public Version
- 3
- Public Version Date
- 2021-07-22
- Public Version Status
- Update
- Public Device Record Key
- 1af85d67-b84f-4366-9f92-5f292af83ab7
Device Description
Power Supply for use with Model 7500
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36545 | Basic power supply, reusable | A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00849686070187 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00833166007558 | GS1 |
Customer Contacts
- Phone
- 763 553 9968
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius