FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10080196114511
·
Model: DYK1066579A
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10080196114511
- Version / Model
- DYK1066579A
- Catalog Number
- DYK1066579A
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 61e4b951-7a85-4bdd-9c3d-85c40e4a7694
Device Description
DREW MEM HOSP ADULT PLUS MRSA KIT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRO | General surgery tray | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47287 | MRSA culture isolate nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid conferring methicillin resistance in methicillin-resistant Staphylococcus aureus (MRSA) bacteria isolated by culture from a clinical specimen, using a nucleic acid technique (NAT). | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40080196114512 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 10080196114511 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]