NA
- Primary DI
- 04713616092425
- Brand
- NA
- Company
- CARILEX MEDICAL, INC.
- Model
- S2101-2100
- Device description
- Relief Aire APM M-set 36'' × 84'' QLT H&R
- Published
- 2017-03-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| FNM | Mattress, Air Flotation, Alternating Pressure |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | General Hospital | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04713616092425 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Alternating-pressure bed mattress overlay system | An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, 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. |
Regulatory Flags
- DUNS number
- 658863238
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 04719893356922 | Wellell | Wellell Inc. | FNM | 2026-03-20 |
| 00860013391003 | ThinAIR | THIN AIR SURFACES, LLC | FNM | 2026-03-10 |
| 00860013391010 | ThinAIR | THIN AIR SURFACES, LLC | FNM | 2026-03-10 |
| 00860013391027 | ThinAIR | THIN AIR SURFACES, LLC | FNM | 2026-03-10 |
| 00860013391034 | ThinAIR | THIN AIR SURFACES, LLC | FNM | 2026-03-10 |
| 00860013391041 | ThinAIR | THIN AIR SURFACES, LLC | FNM | 2026-03-10 |
| 00810178887040 | Vive | VIVE HEALTH LLC | FNM | 2026-03-06 |
| 00810178887057 | Vive | VIVE HEALTH LLC | FNM | 2026-03-06 |
| H93392270 | Span-America | SPAN-AMERICA MEDICAL SYSTEMS, INC. | FNM | 2026-02-25 |
| 04719893356540 | Wellell | Wellell Inc. | FNM | 2026-02-11 |
| 00810178884193 | Vive | VIVE HEALTH LLC | FNM | 2026-02-02 |
| 00810178884483 | Vive | VIVE HEALTH LLC | FNM | 2026-01-30 |
| 05059441536024 | AtmosAir Velaris | Arjohuntleigh AB | FNM | 2026-01-15 |
| 05059441536031 | AtmosAir Velaris | Arjohuntleigh AB | FNM | 2026-01-15 |
| 05059441536048 | AtmosAir Velaris | Arjohuntleigh AB | FNM | 2026-01-15 |
| 05059441536055 | AtmosAir Velaris | Arjohuntleigh AB | FNM | 2026-01-15 |
| 05059441536062 | AtmosAir Velaris | Arjohuntleigh AB | FNM | 2026-01-15 |
| 05059441536079 | AtmosAir Velaris | Arjohuntleigh AB | FNM | 2026-01-15 |
| 08592654544112 | OPTICARE | L I N E T spol. s r.o. | FNM | 2026-01-07 |
| 00860014621895 | Thrive Medical | Supply Line Medical | FNM | 2025-12-26 |
| 00860015100412 | Thrive Medical | Supply Line Medical | FNM | 2025-12-26 |
| 00860015100429 | Thrive Medical | Supply Line Medical | FNM | 2025-12-26 |
| 04719873698608 | NA | CARILEX MEDICAL, INC. | FNM | 2025-12-22 |
| 04719873698615 | NA | CARILEX MEDICAL, INC. | FNM | 2025-12-22 |
| 14719873698629 | NA | CARILEX MEDICAL, INC. | FNM | 2025-12-22 |
| 14719873698636 | NA | CARILEX MEDICAL, INC. | FNM | 2025-12-22 |
| 05061105057455 | Protekt VX 5000 | PROACTIVE MEDICAL PRODUCTS, LLC | FNM | 2025-12-18 |
| 10193489148305 | MEDLINE | MEDLINE INDUSTRIES, INC. | FNM | 2025-12-12 |
| 10197344066100 | MEDLINE | MEDLINE INDUSTRIES, INC. | FNM | 2025-12-12 |
| 10197344172856 | MEDLINE | MEDLINE INDUSTRIES, INC. | FNM | 2025-12-12 |