FDA UDI
In Commercial Distribution
🇺🇸 United States
AcuCare
DI: 00619498609802
·
Model: F1-0
·
RESMED PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- AcuCare
- Primary DI
- 00619498609802
- Version / Model
- F1-0
- Catalog Number
- 60980
- Company Name
- RESMED PTY LTD
- Labeler DUNS
- 751149311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2017-02-10
- Public Version
- 5
- Public Version Date
- 2023-07-28
- Public Version Status
- Update
- Public Device Record Key
- 0586ce54-50ed-466f-8be9-08b011ee93c5
Device Description
NV AcuCare F1-0 FFM SML - 5pk
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| BSJ | Mask, Gas, Anesthetic | Anesthesiology | 868.5550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57814 | CPAP/BPAP face mask, reusable | A 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 and/or 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00619498609802 | GS1 | ||||
| Unit of Use | 10619498607508 | GS1 |
Customer Contacts
- Phone
- 800-424-0737
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity