FDA UDI
In Commercial Distribution
🇺🇸 United States
AquaGuard
DI: 20618125192360
·
Model: 50012-CSE
·
TIDI PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
98
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- AquaGuard
- Primary DI
- 20618125192360
- Version / Model
- 50012-CSE
- Catalog Number
- 50012-CSE
- Company Name
- TIDI PRODUCTS, LLC
- Labeler DUNS
- 063519193
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 98
- Record Status
- Published
- Publish Date
- 2026-04-17
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- 5c3a055c-15ab-49fc-ab27-f087489820bf
Device Description
SHOWER PROTECTION 14IN X 12IN MOISTURE BARRIER
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00618125192366 | GS1 | ||||
| Primary | 20618125192360 | GS1 | ||||
| Previous | 00618125190386 | GS1 |