FDA UDI
In Commercial Distribution
🇺🇸 United States
JOHN BUNN
DI: M368JB020201
·
Model: JB02020
·
GF HEALTH PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- JOHN BUNN
- Primary DI
- M368JB020201
- Version / Model
- JB02020
- Catalog Number
- JB02020
- Company Name
- GF HEALTH PRODUCTS, INC.
- Labeler DUNS
- 132016168
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-05
- Public Version
- 2
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 65427c57-d20a-415b-b75f-d2cc10da3027
Device Description
Finger Pulse Oximeter
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
- 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 |
|---|---|---|---|---|
| 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 | M368020202 | HIBCC | Box | 136 | In Commercial Distribution | |
| Primary | M368JB020201 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K063641 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep at Room Temperature