FDA UDI
In Commercial Distribution
🇺🇸 United States
SARA FLEX
DI: 05055982793445
·
Model: TSS.503
·
Arjohuntleigh AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SARA FLEX
- Primary DI
- 05055982793445
- Version / Model
- TSS.503
- Company Name
- Arjohuntleigh AB
- Labeler DUNS
- 355804758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-03
- Public Version
- 1
- Public Version Date
- 2022-09-12
- Public Version Status
- New
- Public Device Record Key
- 5a7f3a13-122a-4616-966d-02b680c18669
Device Description
Sara Flex standing sling - XL
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
- 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 |
|---|---|---|---|---|
| FSA | Lift, Patient, Non-Ac-Powered | General Hospital | 880.5510 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37480 | General-purpose patient lifting system sling/harness | A general-purpose 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 position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055982793445 | GS1 |