FDA UDI
In Commercial Distribution
🇺🇸 United States
EasyPoint®
DI: 00613703260109
·
Model: 26011
·
RETRACTABLE TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EasyPoint®
- Primary DI
- 00613703260109
- Version / Model
- 26011
- Catalog Number
- 26011
- Company Name
- RETRACTABLE TECHNOLOGIES, INC.
- Labeler DUNS
- 838024255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-18
- Public Version
- 1
- Public Version Date
- 2023-04-26
- Public Version Status
- New
- Public Device Record Key
- 8a2f2d4b-860b-4ebc-b9e0-7592247e39f8
Device Description
22G x 1 1/4" EasyPoint® Blood Collection Tube Holder with Needle
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
- 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 | 00613703260116 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00613703260109 | GS1 |
Customer Contacts
- Phone
- 972-294-1010
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202325 | 000 |