FDA UDI
In Commercial Distribution
🇺🇸 United States
CT 5000
DI: 05708590376585
·
Model: R8455512
·
Pressalit A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CT 5000
- Primary DI
- 05708590376585
- Version / Model
- R8455512
- Catalog Number
- R8455512000
- Company Name
- Pressalit A/S
- Labeler DUNS
- 305656662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-01
- Public Version
- 1
- Public Version Date
- 2021-12-09
- Public Version Status
- New
- Public Device Record Key
- bc8fd76c-1397-42f8-865b-508514c0ab16
Device Description
CT 5000 change table, lying surface in compact laminate, 27.6 x 47.2'' , white. With safety rail and body belt, foldable, fixed height, wall-mounted
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| INT | Plinth | Physical Medicine | 890.3520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43600 | Bathing/changing table, stationary | A raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off), either mounted on a fixed frame with legs or wall-mounted (may be height-adjustable), designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff) or shower. The device is used primarily for a patient with a disability incapable of supporting themself in an upright position. It is designed to be stationary and is used in one location. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05708590376585 | GS1 |
Customer Contacts
- Phone
- +4587888788
- [email protected]