FDA UDI
In Commercial Distribution
🇺🇸 United States
Marketlab Inc
DI: 00817517020403
·
Model: 42830
·
MARKETLAB INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
65
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Basic Information
- Brand Name
- Marketlab Inc
- Primary DI
- 00817517020403
- Version / Model
- 42830
- Catalog Number
- 42830
- Company Name
- MARKETLAB INC.
- Labeler DUNS
- 848917027
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 65
- Record Status
- Published
- Publish Date
- 2018-11-16
- Public Version
- 2
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- f2f5d8f1-f270-4f79-aa82-ab4e99b3ef45
Device Description
SampLok® Adapter Cap 3 Insert for 42829 PK65
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817517020403 | GS1 | ||||
| Unit of Use | 00817517021226 | GS1 |
Customer Contacts
- Phone
- +1(866) 237-3722
- [email protected]