FDA UDI
Not in Commercial Distribution
🇺🇸 United States
INVACARE® MICROAIR® THERAPEUTIC SUPPORT SURFACE
DI: 00841447101970
·
Model: MA85RSR
·
INVACARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INVACARE® MICROAIR® THERAPEUTIC SUPPORT SURFACE
- Primary DI
- 00841447101970
- Version / Model
- MA85RSR
- Company Name
- INVACARE CORPORATION
- Labeler DUNS
- 076916246
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 3
- Public Version Date
- 2023-09-22
- Public Version Status
- Update
- Public Device Record Key
- 2b191e8a-3085-47bc-a86a-e92be7b9093a
- Distribution End Date
- 2023-09-21
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| FNM | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | General Hospital | 880.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17593 | Low-air-loss bed | A mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841447101970 | GS1 |
Customer Contacts
- Phone
- +1(440)329-6000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Maximum Product Weight Capacity: 350 Pounds |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius