FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Nonin
DI: 00849686074062
·
Model: 9570
·
NONIN MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Nonin
- Primary DI
- 00849686074062
- Version / Model
- 9570
- Company Name
- NONIN MEDICAL, INC.
- Labeler DUNS
- 174959692
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 7
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- cf12c3e5-8079-45aa-9f9d-df61bd1b4250
- Distribution End Date
- 2019-08-23
Device Description
GO2 Finger Pulse Oximeter, White
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45607 | Pulse oximeter | An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00833166008371 | GS1 | Clamshell | 1 | Not in Commercial Distribution | 2019-08-23 |
| Primary | 00849686074062 | GS1 | ||||
| Package | 00833166001662 | GS1 | Clamshell | 1 | Not in Commercial Distribution | 2019-08-23 |
Customer Contacts
- Phone
- 763 553 9968
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Infant | ||
| Device Size Text, specify | Pediatric | ||
| Device Size Text, specify | Adult |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -22 – 122 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 50 Degrees Celsius