FDA UDI
In Commercial Distribution
🇺🇸 United States
Rescuer Emergency CPAP System
DI: B00287050
·
Model: 8705
·
B.L.S. Systems Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Rescuer Emergency CPAP System
- Primary DI
- B00287050
- Version / Model
- 8705
- Catalog Number
- 8705
- Company Name
- B.L.S. Systems Limited
- Labeler DUNS
- 200103823
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-05-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2eecb79d-c459-4134-8a4c-1a0ee0806b56
Device Description
Rescuer Emergency CPAP System with Medium sized CPAP mask and pre-attached bonnet used for acute episodes of respiratory distress.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | Anesthesiology | 868.5965 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57813 | CPAP/BPAP face mask, single-use | A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B00287050 | HIBCC |
Customer Contacts
- Phone
- 9053391069
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122610 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Medium CPAP Mask |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- -40 – 60 Degrees Celsius