FDA UDI
In Commercial Distribution
🇺🇸 United States
ONE-CARE Safety Blood Collection Needles
DI: 00810008212899
·
Model: 5020-H ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' with Holders
·
MediVena, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- ONE-CARE Safety Blood Collection Needles
- Primary DI
- 00810008212899
- Version / Model
- 5020-H ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' with Holders
- Catalog Number
- 5020-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
- 6fe3aea4-c3c3-47aa-9e65-ffabecc444e4
Device Description
ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' with Holders, Black, 100/bx, 5bx/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 |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58284 | Blood collection tube holder/needle | A sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810008212905 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00810008212899 | GS1 | ||||
| Package | 00810008212912 | GS1 | Case | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 4045142586
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172763 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 22 | Gauge | |
| Length | 1.25 | Inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit