FDA UDI
In Commercial Distribution
🇺🇸 United States
ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets
DI: 00810008212653
·
Model: 5062-H ONE-CARE PRESS & LOCK SBCWS 21G x 0.75’’, Pre-Attached Holder, 12'' Tube
·
MediVena, LLC
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets
- Primary DI
- 00810008212653
- Version / Model
- 5062-H ONE-CARE PRESS & LOCK SBCWS 21G x 0.75’’, Pre-Attached Holder, 12'' Tube
- Catalog Number
- 5062-H
- Company Name
- MediVena, LLC
- Labeler DUNS
- 080740980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-27
- Public Version
- 1
- Public Version Date
- 2024-10-07
- Public Version Status
- New
- Public Device Record Key
- c1422c38-5833-4a1f-86e4-13f09e2affa8
Device Description
ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets 21G x 0.75’’, Green, 12'' Tube, Pre-Attached Holder, 25/bx, 20bx/cs
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
- Yes
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60579 | Luer-ended blood collection tube spike | A device intended to be used during patient blood collection to facilitate transfer of a clinical blood specimen from blood collection tubing or a needle to a blood specimen receptacle (e.g., evacuated blood collection tube, adapted syringe). It is designed to be fitted to a blood collection tube holder, where it connects to the tubing or needle via a Luer connection at one end, and penetrates an evacuated blood collection tube at the other end for blood collection. This is a single-use device. | No | Active |
| 65416 | Basic intravenous administration set, invasive | A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810008212660 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 00810008212653 | GS1 | ||||
| Package | 00810008212677 | GS1 | Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 4045142586
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151991 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 21 | Gauge | |
| Length | 0.75 | Inch |