FDA UDI
In Commercial Distribution
🇺🇸 United States
Tortoise™ Turning & positioning system
DI: 07323190277704
·
Model: 1400800
·
Mölnlycke Health Care AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Tortoise™ Turning & positioning system
- Primary DI
- 07323190277704
- Version / Model
- 1400800
- Company Name
- Mölnlycke Health Care AB
- Labeler DUNS
- 631770658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-21
- Public Version
- 2
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 5a28bad0-2159-45f9-9894-7a8753b7d50a
Device Description
Standard Tortoise
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMR | DEVICE, TRANSFER, PATIENT, MANUAL | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37165 | Patient transfer/turning sheet, single-use | A manual device in the form of a sturdy sheet intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07323190277377 | GS1 | PACK_OR_INNER_PACK | 1 | In Commercial Distribution | |
| Primary | 07323190277704 | GS1 | ||||
| Package | 07323190277360 | GS1 | CASE | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +46737733775
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Standard |