FDA UDI
In Commercial Distribution
🇺🇸 United States
Microbank (with 2D Barcodes) -Blue (80 vials)
DI: 10628429002138
·
Model: PL.170C/B
·
PRO-LAB, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Microbank (with 2D Barcodes) -Blue (80 vials)
- Primary DI
- 10628429002138
- Version / Model
- PL.170C/B
- Catalog Number
- PL.170C/B
- Company Name
- PRO-LAB, INCORPORATED
- Labeler DUNS
- 960418395
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-21
- Public Version
- 1
- Public Version Date
- 2022-12-29
- Public Version Status
- New
- Public Device Record Key
- b722e398-1925-4d37-b3d5-9d98d1147fb1
Device Description
Advanced presentation of 80 vials with blue caps and beads supplied in a plastic freezer box manufactured from durable plastic with “see through” lids, number locator printed screens, and tube collection device.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| JSC | Culture Media, General Nutrient Broth | Microbiology | 866.2350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58586 | Basic/simple nutrient broth culture medium IVD | A non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10628429002138 | GS1 |