FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDLINE INDUSTRIES, INC.
DI: 10884389109854
·
Model: MSC093001
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MEDLINE INDUSTRIES, INC.
- Primary DI
- 10884389109854
- Version / Model
- MSC093001
- Catalog Number
- MSC093001
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-19
- Public Version
- 1
- Public Version Date
- 2021-05-27
- Public Version Status
- New
- Public Device Record Key
- 2e0170ac-de5b-4897-9212-c339b081b079
Device Description
PROTECTANT,SKIN,MARATHON,LIQUID
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 62535 | Skin-cover sealant | A biodegradable, synthetic (e.g., cyanoacrylate) substance intended to be applied over a superficial wound to set and form a barrier to reduce skin exposure to external contaminants. Sometimes referred to as a liquid bandage, it is intended for use in the home or a clinical setting and may be intended as an alternative to a conventional skin-cover adhesive strip. 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 | 40884389109855 | GS1 | CASE | 5 | In Commercial Distribution | |
| Primary | 10884389109854 | GS1 | ||||
| Package | 30884389109858 | GS1 | BOX | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133443 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius