FDA UDI
In Commercial Distribution
🇺🇸 United States
Maveric Medical
DI: 00850028131015
·
Model: M6230
·
MAVERIC MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Maveric Medical
- Primary DI
- 00850028131015
- Version / Model
- M6230
- Company Name
- MAVERIC MEDICAL LLC
- Labeler DUNS
- 117229530
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-24
- Public Version
- 2
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- c8e3c4b6-54ad-4fd4-8744-13634cfde332
- Distribution End Date
- 2099-09-25
Device Description
Blood Collection Set, Safety, 23G x 3/4", 7" Tubing, Luer Adapter
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
- 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 10850028131012 | GS1 | Box | 50 | In Commercial Distribution | 2099-09-25 |
| Primary | 00850028131015 | GS1 | ||||
| Package | 20850028131019 | GS1 | Case | 1000 | In Commercial Distribution | 2099-09-25 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172763 | 000 |