FDA UDI
In Commercial Distribution
🇺🇸 United States
Parent's Choice
DI: 00194346231423
·
Model: K5101US
·
WAL-MART STORES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Parent's Choice
- Primary DI
- 00194346231423
- Version / Model
- K5101US
- Company Name
- WAL-MART STORES, INC.
- Labeler DUNS
- 051957769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-29
- Public Version
- 1
- Public Version Date
- 2024-11-06
- Public Version Status
- New
- Public Device Record Key
- 5661e9b6-87aa-43b8-802d-e741e04e0787
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| INB | Attachment, Commode, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32616 | Vaginal douche, reusable | A manual device designed to produce and direct a stream of fluid (typically water, water/vinegar solution, or antiseptic chemicals) into the vaginal cavity typically for hygienic purposes, including the removal of vaginal discharge, medicinal deposits, and anticonceptual products from the vagina. It usually consists of a bag, bottle, or bulb to contain the fluid, and tubing often with a nozzle for vaginal insertion; the fluid is ejected upon hand compression by the user. The device is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10194346231420 | GS1 | 4 | In Commercial Distribution | ||
| Primary | 00194346231423 | GS1 | ||||
| Package | 20194346231427 | GS1 | 6 | In Commercial Distribution |