FDA UDI
Not in Commercial Distribution
🇺🇸 United States
INVACARE® CAREGUARD™ ALTERNATING PRESSURE PAD SYSTEM
DI: 00841447101765
·
Model: CG9701
·
INVACARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INVACARE® CAREGUARD™ ALTERNATING PRESSURE PAD SYSTEM
- Primary DI
- 00841447101765
- Version / Model
- CG9701
- 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
- 2b662bb4-049b-49b7-8dc6-eec661c239c3
- 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 |
|---|---|---|---|---|
| 47476 | Air-filled bed mattress overlay | A static-air-inflated pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841447101765 | GS1 |
Customer Contacts
- Phone
- +1(440)329-6000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Maximum Product Weight Capacity: 250 Pounds |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius