FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DRIVE
DI: 00822383000817
·
Model: RTL5021F
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DRIVE
- Primary DI
- 00822383000817
- Version / Model
- RTL5021F
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-08
- Public Version
- 2
- Public Version Date
- 2020-04-24
- Public Version Status
- Update
- Public Device Record Key
- f88269e8-134d-4c30-ace0-3a142c71480b
- Distribution End Date
- 2020-04-24
Device Description
Personal Care Aids to Daily Living Product Description 32" Foldable Reacher,1EA,6/CS
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 |
|---|---|---|---|---|
| IKX | AID, TRANSFER | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33886 | Assistive bathing scrub brush | A device designed to be used by a person with a disability to assist them in attending to their personal body washing needs. It is a brush with a purpose-made handle or grip that allows the user to wash/scrub all parts of their body whilst bathing; particularly the parts that they cannot reach using their hands. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00822383000817 | GS1 | ||||
| Previous | 00822384002216 | GS1 |