NA
- Primary DI
- 04713616091053
- Brand
- NA
- Company
- CARILEX MEDICAL, INC.
- Model
- S2001-A280
- Device description
- Relief Aire LAL Cover 36'' × 80'' QLT H&R-1p
- 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 |
|---|
| IOQ | Bed, Flotation Therapy, Powered |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IOQ | Bed, Flotation Therapy, Powered | Physical Medicine | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04713616091053 | Package | GS1 | 10 | In Commercial Distribution |
| 14713616093191 | Package | GS1 | 10 | In Commercial Distribution |
| 04713616093194 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04713616091053 | 04713616091053 | 4713616091053 |
| 14713616093191 | 14713616093191 | |
| 04713616093194 | 04713616093194 | 4713616093194 |
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
- true
- Serial number
- false
- 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
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Other Devices Sharing Product Codes
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|---|
| 08592654562703 | Multicare X | L I N E T spol. s r.o. | IOQ | 2026-01-07 |
| 08592654550441 | Multicare | L I N E T spol. s r.o. | IOQ | 2025-12-22 |
| 08592654510407 | Multicare | L I N E T spol. s r.o. | IOQ | 2025-05-26 |
| 00817012031669 | K-3 AIRE-ZONE | KAP MEDICAL | IOQ | 2025-04-04 |
| M368LS900361 | LUMEX | GF HEALTH PRODUCTS, INC. | IOQ | 2025-03-01 |
| M368LS900421 | LUMEX | GF HEALTH PRODUCTS, INC. | IOQ | 2025-03-01 |
| M368LS900481 | LUMEX | GF HEALTH PRODUCTS, INC. | IOQ | 2025-03-01 |
| M368LS900MAT361 | LUMEX | GF HEALTH PRODUCTS, INC. | IOQ | 2025-03-01 |
| M368LS900MAT421 | LUMEX | GF HEALTH PRODUCTS, INC. | IOQ | 2025-03-01 |
| M368LS900MAT481 | LUMEX | GF HEALTH PRODUCTS, INC. | IOQ | 2025-03-01 |
| M369LS900P1 | LUMEX | GF HEALTH PRODUCTS, INC. | IOQ | 2025-03-01 |
| 00887761007710 | Centrella™ Surface | HILL-ROM, INC. | IOQ | 2024-11-27 |
| 00887761007727 | Centrella™ Surface | HILL-ROM, INC. | IOQ | 2024-11-27 |
| 00887761007734 | Centrella™ Surface | HILL-ROM, INC. | IOQ | 2024-11-27 |
| 00887761007741 | Centrella™ Surface | HILL-ROM, INC. | IOQ | 2024-11-27 |
| 00887761007758 | Centrella™ Surface | HILL-ROM, INC. | IOQ | 2024-11-27 |
| 00887761007765 | Centrella™ Surface | HILL-ROM, INC. | IOQ | 2024-11-27 |
| 08592654466933 | Multicare X | L I N E T spol. s r.o. | IOQ | 2024-10-23 |
| 00887761966819 | Centrella™ Surface | HILL-ROM, INC. | IOQ | 2024-09-20 |
| 10670482000774 | oneNEST M | Umano Medical Inc | IOQ | 2024-06-21 |
| 06977071938102 | Meicen | Guangdong Meicen Medical Equipment Co., Ltd. | IOQ | 2024-06-21 |
| 04719873696901 | NA | CARILEX MEDICAL, INC. | IOQ | 2024-06-20 |
| 14719873696915 | NA | CARILEX MEDICAL, INC. | IOQ | 2024-06-20 |
| 04719873696925 | NA | CARILEX MEDICAL, INC. | IOQ | 2024-06-20 |
| 14719873696939 | NA | CARILEX MEDICAL, INC. | IOQ | 2024-06-20 |
| 00817012031485 | K-3oem EZ-AIRE | KAP MEDICAL | IOQ | 2024-06-14 |
| 10670482000781 | oneNEST M | Umano Medical Inc | IOQ | 2024-06-07 |
| 10670482000798 | oneNEST M Control unit | Umano Medical Inc | IOQ | 2024-06-07 |
| 10670482000804 | oneNEST M Control unit | Umano Medical Inc | IOQ | 2024-06-07 |
| 00887761967182 | Progressa+ surface | Hill-Rom de México, S. de R.L. de C.V. | IOQ | 2024-05-31 |