FDA UDI
In Commercial Distribution
🇺🇸 United States
MCT 5
DI: 05708590389868
·
Model: R95027
·
Pressalit A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MCT 5
- Primary DI
- 05708590389868
- Version / Model
- R95027
- Catalog Number
- R9502717000
- Company Name
- Pressalit A/S
- Labeler DUNS
- 305656662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-05
- Public Version
- 1
- Public Version Date
- 2024-11-13
- Public Version Status
- New
- Public Device Record Key
- 387e3598-dceb-4742-a612-5b2cb1b94340
Device Description
MCT 5 change trolley, 700 x 1700 mm, two fold-down sides, white. Manually height adjustable with foot pedal
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
- MR Safe
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| INW | Table, Mechanical | Physical Medicine | 890.3750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43494 | Bathing/changing table, mobile | 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) mounted on a foldable frame with legs 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). The device is used primarily for a patient with a disability incapable of supporting themself in an upright position for bathing. It is designed to be portable or easily moved on wheels to different locations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05708590389868 | GS1 |
Customer Contacts
- Phone
- +4587888788
- [email protected]