FDA UDI
In Commercial Distribution
🇺🇸 United States
MedSource I.V. Guard
DI: 00816703024539
·
Model: MS-11102
·
MEDSOURCE INTERNATIONAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MedSource I.V. Guard
- Primary DI
- 00816703024539
- Version / Model
- MS-11102
- Catalog Number
- Not Applicable
- Company Name
- MEDSOURCE INTERNATIONAL LLC
- Labeler DUNS
- 041674552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-28
- Public Version
- 1
- Public Version Date
- 2021-05-06
- Public Version Status
- New
- Public Device Record Key
- 8a537649-384a-4cf7-a459-233e71506c39
Device Description
Pedi IV Guard Catheter Dressing
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58302 | Antimicrobial synthetic polymer semi-permeable film dressing, adhesive | A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue to provide protection (e.g., from dirt, water) and/or promote healing, and that contains an antimicrobial agent. It is a thin, clear film made of synthetic polymer with a pressure-sensitive adhesive on one side that may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions, ulcers, burns, lacerations, abrasions, device insertion sites, and donor/graft sites. It may also be used to secure to skin other devices (e.g., catheters, drains, leads, ports). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840155407848 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00816703024539 | GS1 | ||||
| Package | 00816703024546 | GS1 | Case | 500 | In Commercial Distribution |