FDA UDI
In Commercial Distribution
🇺🇸 United States
Marketlab Inc
DI: 00817517020724
·
Model: 7134
·
MARKETLAB INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Marketlab Inc
- Primary DI
- 00817517020724
- Version / Model
- 7134
- Catalog Number
- 7134
- Company Name
- MARKETLAB INC.
- Labeler DUNS
- 848917027
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-11-16
- Public Version
- 1
- Public Version Date
- 2018-12-17
- Public Version Status
- New
- Public Device Record Key
- 9a0e13e1-db33-47d6-965c-1f944cc659b3
Device Description
IB Filter Sampler Blood Serum Filters 13mm x 2.75 Inch L- 100/pk
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| JKA | Tubes, vials, systems, serum separators, blood collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58386 | Centrifugal sample concentrator | A mains electricity (AC-powered) laboratory device designed to condense fluid clinical specimens (e.g., serum, urine, cerebrospinal fluid, ascites) using centrifugal rotation in order to harvest and preserve the particulate matter. Commonly known as a cyto-spin, it separates fluid from the solid particles, or cellular elements, of a specimen so they are more concentrated. It typically consists of a centrifuge with various rotor heads, microtitre plates, tubes, microscope slides, funnels and/or cups to which the sample is added, and absorptive material, filters, fluid collecting traps or a vacuum source utilized to separate and remove the liquid component. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817517020724 | GS1 | ||||
| Unit of Use | 00817517021523 | GS1 |
Customer Contacts
- Phone
- +1(866) 237-3722
- [email protected]