FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10080196756988
·
Model: MDS200100C
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10080196756988
- Version / Model
- MDS200100C
- Catalog Number
- MDS200100C
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-02
- Public Version
- 2
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- bf23ba4f-384a-4e75-95bf-85120c9315e4
Device Description
STRIP,STEAM INDICATOR,4",18BX/CS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| LRT | INDICATOR, STERILIZATION | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35362 | Chemical/physical sterilization process indicator | A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30080196756982 | GS1 | BOX | 250 | In Commercial Distribution | |
| Primary | 10080196756988 | GS1 | ||||
| Package | 40080196756989 | GS1 | CASE | 4500 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]