FDA UDI
In Commercial Distribution
🇺🇸 United States
Tortoise™ Turning & positioning system
DI: 07323190301676
·
Model: 1400808
·
Mölnlycke Health Care AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tortoise™ Turning & positioning system
- Primary DI
- 07323190301676
- Version / Model
- 1400808
- Company Name
- Mölnlycke Health Care AB
- Labeler DUNS
- 631770658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-09
- Public Version
- 1
- Public Version Date
- 2022-12-19
- Public Version Status
- New
- Public Device Record Key
- b8c4fb72-9815-4a41-9ac9-29c9aaf6ec82
Device Description
Tortoise Sling bariatric
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
- 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 |
|---|---|---|---|---|
| 38869 | Patient lifting system hammock sling | A lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting or semi-recumbent position with their body (back, head, arms, buttocks and upper legs) enveloped within the sling. It is typically designed as a rectangular piece of strengthened fabric with lifting straps or eyes; it may be with or without a commode aperture. This type of sling disperses the body weight over a large area of material reducing the likelihood of pressure sores; no user cooperation is required. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07323190301676 | GS1 |
Customer Contacts
- Phone
- +46737733775
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Bariatric |