FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Breas iSleep 20+ system
DI: 07321822060007
·
Model: US
·
Breas Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Breas iSleep 20+ system
- Primary DI
- 07321822060007
- Version / Model
- US
- Catalog Number
- 206000
- Company Name
- Breas Medical AB
- Labeler DUNS
- 357007657
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2021-02-11
- Public Version Status
- Update
- Public Device Record Key
- 7e5e6162-1269-42d2-bed9-0d9db52b800b
- Distribution End Date
- 2018-01-15
Device Description
Ventilator Non-continuous (Respirator)
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 |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | Anesthesiology | 868.5905 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60711 | Home CPAP unit | A portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07321822060168 | GS1 | Box | 1 | Not in Commercial Distribution | 2018-01-15 |
| Primary | 07321822060007 | GS1 |
Customer Contacts
- Phone
- +4631868860
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061057 | 000 |