FDA UDI
In Commercial Distribution
🇺🇸 United States
Inspired by Drive
DI: 00822383936048
·
Model: BLA-8100
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Inspired by Drive
- Primary DI
- 00822383936048
- Version / Model
- BLA-8100
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-20
- Public Version
- 1
- Public Version Date
- 2020-02-28
- Public Version Status
- New
- Public Device Record Key
- 8c62a06a-752a-41d2-b1e0-007f2f6f46ed
Device Description
AquaLift Bath System
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 35961 | Patient lifting system lift pants | A lifting device used together with a mobile lift system (normally a ceiling-mounted overhead track system) to provide a support for an incapacitated patient or a person with a disability that has been raised from a sitting position and held in a standing position for mobility training; it is primarily used for confidence building when walking. It is designed as a sling construction made of straps attached to a pants-like holder which is placed between the users' legs (the crotch) and secured high around the waist which will cradle the hip section of their body allowing them to maintain balance whilst moving slowly forward using their feet. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00822383936048 | GS1 |