FDA UDI
In Commercial Distribution
🇺🇸 United States
VanishPoint®
DI: 00613703227010
·
Model: 22701
·
RETRACTABLE TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- VanishPoint®
- Primary DI
- 00613703227010
- Version / Model
- 22701
- Catalog Number
- 22701
- Company Name
- RETRACTABLE TECHNOLOGIES, INC.
- Labeler DUNS
- 838024255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 5
- Public Version Date
- 2019-04-23
- Public Version Status
- Update
- Public Device Record Key
- e2a5a4b5-783e-4387-bcea-a4f28365e636
Device Description
VanishPoint® Blood Collection Tube Holder
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37566 | Blood collection tube holder, single-use | A hand-held cylindrical device 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 into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device 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 | 00613703227027 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 00613703227010 | GS1 | ||||
| Unit of Use | 00613703227058 | GS1 |
Customer Contacts
- Phone
- 888-703-1010
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K971763 | 000 |