FDA UDI
In Commercial Distribution
🇺🇸 United States
WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUS
DI: 05600494138736
·
Model: BLS5
·
INVACARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUS
- Primary DI
- 05600494138736
- Version / Model
- BLS5
- Company Name
- INVACARE CORPORATION
- Labeler DUNS
- 076916246
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-15
- Public Version
- 1
- Public Version Date
- 2024-08-23
- Public Version Status
- New
- Public Device Record Key
- 8e9a3815-4404-463e-9976-fef44fd7c1d4
Device Description
WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUS
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 |
|---|---|---|---|---|
| FRW | Scale, Patient | General Hospital | 880.2720 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35996 | Patient sling scale | A transportable electronic device designed to lift an immobile patient, typically bedridden, in a sling in order to measure and/or monitor their body weight. It typically consists of a wheeled framework that includes a lifting mechanism (e.g., a hydraulic pump), a patient sling (to encompass the patient's body), a lifting arm, hooks, and an electronic scale (typically incorporating strain gauge transducers). The sling is placed under/around the patient and the lifting arm is used to lift the patient until their whole body is suspended; the scale subsequently displays the measured weight of the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05600494138736 | GS1 |
Customer Contacts
- Phone
- +14403296000
- [email protected]