FDA UDI
In Commercial Distribution
🇺🇸 United States
3M™ Cavilon™
DI: 50707387793604
·
Model: 3344ENS
·
3M COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
Basic Information
- Brand Name
- 3M™ Cavilon™
- Primary DI
- 50707387793604
- Version / Model
- 3344ENS
- Catalog Number
- 3344ENS
- Company Name
- 3M COMPANY
- Labeler DUNS
- 830016148
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 3b8a6943-98d1-41c1-89de-31f476310abc
Device Description
3M™ Cavilon™ No Sting Barrier Film, 3344ENS, 1ML Wipe, 200 Each/Case
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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KMF | Bandage, liquid | General Hospital | 880.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58979 | Synthetic-polymer liquid barrier dressing, sterile | A sterile liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00707387791889 | GS1 | ||||
| Primary | 50707387793604 | GS1 |
Customer Contacts
- Phone
- +1(800)228-3957
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955103 | 000 |