FDA UDI
In Commercial Distribution
🇺🇸 United States
DRIVEMEDICAL
DI: 00822383563176
·
Model: RTLPC23402
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DRIVEMEDICAL
- Primary DI
- 00822383563176
- Version / Model
- RTLPC23402
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-02
- Public Version
- 2
- Public Version Date
- 2019-11-27
- Public Version Status
- Update
- Public Device Record Key
- b2b8c440-2c1f-4c58-a94a-dd5b8d94b0f0
Device Description
Personal CareAids to Daily Living Product Description: Cast Protector,24.5" Leg, 1 PC/RTL,50/CV
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
- 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 |
|---|---|---|---|---|
| KIA | COVER, CAST | General Hospital | 880.6185 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33536 | Cast/bandage waterproof bathing cover, single-use | A device made of waterproof materials designed to be placed over a treated area of the body, typically a plaster cast, stitches, bandage, dressing, or PICC line, to keep the area dry while the user is having a shower or a bath. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50822383563171 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00822383563176 | GS1 |