FDA UDI
In Commercial Distribution
🇺🇸 United States
BD ChloraShield™ IV Nexiva™ Dressing with CHG Antimicrobial
DI: 10885403430022
·
Model: 410123
·
Avery Dennison Belgie BVBA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BD ChloraShield™ IV Nexiva™ Dressing with CHG Antimicrobial
- Primary DI
- 10885403430022
- Version / Model
- 410123
- Company Name
- Avery Dennison Belgie BVBA
- Labeler DUNS
- 370514887
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-15
- Public Version
- 2
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- fb6bdbcc-9b99-4e29-8001-b67fb75aec34
Device Description
BD ChloraShield™ IV Nexiva™ Dressing with Chlorhexidine Gluconate (CHG) Antimicrobial for BD Nexiva™ Closed Catheter Systems, 3.3 x 2.4 in (83 x 60 mm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 48124 | Exudate-absorbent dressing, non-gel, antimicrobial | A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403430020 | GS1 | Tertiary (shipper) | 10 | In Commercial Distribution | |
| Package | 20885403430029 | GS1 | Secondary (carton) | 100 | In Commercial Distribution | |
| Primary | 10885403430022 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit