FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica® VTR Syringes
DI: 00709078013447
·
Model: 11561348
·
WESTMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Atellica® VTR Syringes
- Primary DI
- 00709078013447
- Version / Model
- 11561348
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2022-02-28
- Public Version
- 1
- Public Version Date
- 2022-03-08
- Public Version Status
- New
- Public Device Record Key
- 952e02d4-0565-41eb-b1ea-22cecc63c9cb
Device Description
3mL Vented Luer Slip Syringe 22g x 1" Needle, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap, Q-Cork (Private Label)
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
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 31336 | Arterial blood sampling kit | A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10709078013451 | GS1 | ||||
| Primary | 00709078013447 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K931924 | 000 |