FDA UDI
In Commercial Distribution
🇺🇸 United States
Bathtub
DI: 05707581000393
·
Model: Electric, 180x80cm
·
Ropox A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bathtub
- Primary DI
- 05707581000393
- Version / Model
- Electric, 180x80cm
- Catalog Number
- 40-14158-2
- Company Name
- Ropox A/S
- Labeler DUNS
- 365674936
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 7585dbd4-d9bf-4e12-9fb4-242de976d870
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66051 | Height-adjustable bathtub | A bathing (washing) receptacle designed with an electrically-powered mechanism to adjust its height so it can be lowered to facilitate the entering/exiting of a patient, aided by a patient lift if necessary, and raised to facilitate washing assistance by a caregiver. It may include a folding fenestrated platform on which the patient can lie while using a shower head. It 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 | 05707581000393 | GS1 |
Customer Contacts
- Phone
- +4555750500
- [email protected]