FDA UDI
In Commercial Distribution
🇺🇸 United States
Kendall
DI: 10192253046786
·
Model: 55588BAMDX
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Kendall
- Primary DI
- 10192253046786
- Version / Model
- 55588BAMDX
- Catalog Number
- 55588BAMDX
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-09
- Public Version
- 1
- Public Version Date
- 2025-09-17
- Public Version Status
- New
- Public Device Record Key
- d6c6e1b1-dc89-4cbc-b235-05f16a9fe71a
Device Description
Kendall AMD Antimicrobial Foam Border Dressing 0.5% Polyhexamethylene Biguanide HCl (PHMB) 7.5 x 7.5 in. (19 x 19 cm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| FRO | Dressing, wound, drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47042 | Wound-nonadherent dressing, absorbent, antimicrobial | A wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20192253046783 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 10192253046786 | GS1 | ||||
| Package | 50192253046784 | GS1 | CASE | 5 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7.5 | Inch | |
| Width | 7.5 | Inch |