FDA UDI
In Commercial Distribution
🇺🇸 United States
Rhapsody
DI: 05055982728560
·
Model: AR32212US1111
·
Arjohuntleigh AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Rhapsody
- Primary DI
- 05055982728560
- Version / Model
- AR32212US1111
- Catalog Number
- AR32212US1111
- Company Name
- Arjohuntleigh AB
- Labeler DUNS
- 355804758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-14
- Public Version
- 1
- Public Version Date
- 2024-06-24
- Public Version Status
- New
- Public Device Record Key
- ff326dcc-474b-44aa-9dbe-e020364056ef
Device Description
Bath System - Rhap Sys23 HM P220 Disp Des
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| ILJ | Bath, hydro-massage | Physical Medicine | 890.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14450 | Hydrotherapy bath/tank | A bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. It may have built-in water jet nozzles or an external heating/pump system to heat and circulate the water (whirlpool effect). This device is intended to be used in a healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055982728560 | GS1 |
Customer Contacts
- Phone
- 1(800) 323-1245
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K001079 | 000 |