FDA UDI
In Commercial Distribution
🇺🇸 United States
Q-RIP to Belt Controller Cable for Alice
DI: B1408592A0
·
Model: 8592A
·
Braebon Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Q-RIP to Belt Controller Cable for Alice
- Primary DI
- B1408592A0
- Version / Model
- 8592A
- Catalog Number
- 8592A
- Company Name
- Braebon Medical Corporation
- Labeler DUNS
- 251731105
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-25
- Public Version
- 1
- Public Version Date
- 2024-04-02
- Public Version Status
- New
- Public Device Record Key
- 4638df79-30ba-420f-ac05-e69917c71604
Device Description
Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
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
- 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 |
|---|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | Anesthesiology | 868.2375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35244 | Pneumograph | A device designed to graphically display chest movement during the respiratory cycle. It uses a sensor, e.g. Electrical impedance, to detect and transduce respiratory chest movement and may display both the rate and waveform of the movement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1408592A0 | HIBCC |
Customer Contacts
- Phone
- 613.831.6690
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K001743 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 48 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity