FDA UDI
In Commercial Distribution
🇺🇸 United States
Kendall
DI: 20192253040156
·
Model: 9403
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
2
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Basic Information
- Brand Name
- Kendall
- Primary DI
- 20192253040156
- Version / Model
- 9403
- Catalog Number
- 9403-
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2025-09-26
- Public Version
- 1
- Public Version Date
- 2025-10-06
- Public Version Status
- New
- Public Device Record Key
- e6e520d4-a21d-4517-b901-451cda4bebfa
Device Description
Hydrogel Breast Feeding Pad 3" (7.6 cm)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAE | Dressing, wound, hydrogel without drug and/or biologic | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50192253040157 | GS1 | CASE | 5 | In Commercial Distribution | |
| Package | 40192253040150 | GS1 | Carton | 5 | In Commercial Distribution | |
| Package | 30192253040153 | GS1 | PACK | 2 | In Commercial Distribution | |
| Primary | 20192253040156 | GS1 | ||||
| Unit of Use | 10192253040159 | GS1 |