FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vacuette
DI: 19120017577802
·
Model: 450239
·
Greiner Bio-One GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Vacuette
- Primary DI
- 19120017577802
- Version / Model
- 450239
- Catalog Number
- 450239
- Company Name
- Greiner Bio-One GmbH
- Labeler DUNS
- 303639066
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2022-05-30
- Public Version Status
- Update
- Public Device Record Key
- d98ef440-0c77-46c9-9136-e19d59933904
- Distribution End Date
- 2022-05-27
Device Description
VACUETTE® QUICKSHIELD Complete PLUS 21G x 1 1/2" single-packed, sterile 0.8 x 38 mm
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
- No
- 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 |
|---|---|---|---|---|
| FMI | Needle, hypodermic, single lumen | General Hospital | 880.5570 | 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 | 39120017577806 | GS1 | 10 | Not in Commercial Distribution | 2022-05-27 | |
| Package | 29120017577809 | GS1 | 30 | Not in Commercial Distribution | 2022-05-27 | |
| Primary | 19120017577802 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072320 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 36 Degrees Celsius