FDA UDI
In Commercial Distribution
🇺🇸 United States
MUELLER HINTON
DI: M20211061
·
Model: 1106
·
Healthlink
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
8
Basic Information
- Brand Name
- MUELLER HINTON
- Primary DI
- M20211061
- Version / Model
- 1106
- Catalog Number
- 1106
- Company Name
- Healthlink
- Labeler DUNS
- 079376107
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e28f0b73-3dbd-48bd-9d3d-1a92da4be511
Device Description
MUELLER HINTON
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| JTZ | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH | Microbiology | 866.1700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58639 | Mueller-Hinton agar antimicrobial susceptibility culture medium IVD | A non-selective Mueller-Hinton agar culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on non-fastidious microorganisms in a clinical specimen and/or culture isolate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M20211062 | HIBCC | Box | 3 | In Commercial Distribution | |
| Primary | M20211061 | HIBCC | ||||
| Unit of Use | M20211060 | HIBCC |
Customer Contacts
- Phone
- +1(800)638-2625
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K945911 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 100 | Millimeter | |
| Device Size Text, specify | 100 mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius