Identity
- Trade Name
- BRAEBON Disposable RIP Belt, Large FDA UDI
- Generic Name
- Pneumograph FDA UDI
- Device Name
- Disposable belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier. FDA UDI
- Model / Reference
- 5576-24 FDA UDI
- Description
- Disposable belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier. FDA UDI
Identifiers
- Catalog Number
- 5576-24 FDA UDI
- Primary DI / UDI-DI
- B1405576241 FDA UDI
- 510(k) Number
- K001743 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Pneumograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 40 Inch FDA UDI
Category: Pneumograph
BRAEBON Disposable RIP Belt, Large by Braebon Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumograph.
- PNEUMOGRAPH, CHEST, NON-MAGNETIC, 3160 — Philips DS North America LLC · Class II
- BRAEBON Disposable RIP Belt, Large — Braebon Medical Corp. · Class II
- BRAEBON Disposable RIP Belt, Small — Braebon Medical Corp. · Class II
- BRAEBON 1-Foot Double Buckle Effort Belt — Braebon Medical Corp. · Class II
- BRAEBON Disposable RIP Belt, Small — Braebon Medical Corp. · Class II
- BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 4 — Braebon Medical Corp. · Class II
- BRAEBON Disposable RIP Belt, Medium — Braebon Medical Corp. · Class II
- BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 3 — Braebon Medical Corp. · Class II
Cleared under the same submission
K001743 also covers:
- BRAEBON 1 mm Dual Safety Pin to 2.5 mm Female Phone Connector Cable — Braebon Medical Corp.
- BRAEBON 1 mm Dual Safety Pin to 2.5 mm Male Phone Connector Cable — Braebon Medical Corp.
- BRAEBON 1 mm Dual Safety Pin to 3.5 mm Male Phone Connector Cable — Braebon Medical Corp.
- BRAEBON 1 mm Dual Safety Pin to RJ10 Connector Cable — Braebon Medical Corp.
- BRAEBON 1 mm Dual Safety Pin to RJ11 Connector Cable — Braebon Medical Corp.
- BRAEBON Cable for Disposable RIP — Braebon Medical Corp.
- BRAEBON Cable for Disposable RIP — Braebon Medical Corp.
- BRAEBON Disposable RIP Belt, Large — Braebon Medical Corp.
- BRAEBON Disposable RIP Belt, Medium — Braebon Medical Corp.
- BRAEBON Disposable RIP Belt, Small — Braebon Medical Corp.
- BRAEBON Disposable RIP Belt, Small — Braebon Medical Corp.
- BRAEBON Male Snap to Female Safety Pin Adapter — Braebon Medical Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Braebon Medical Corp.
Sources (1)
- FDA UDI 0395a491-575b-4ee8-a8d1-61bcdd268025 38 fields · synced May 30, 2026