FDA UDI
In Commercial Distribution
🇺🇸 United States
SU-VEID
DI: 07290018896136
·
Model: 18103200
·
ANGIE TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SU-VEID
- Primary DI
- 07290018896136
- Version / Model
- 18103200
- Catalog Number
- 18103200
- Company Name
- ANGIE TECHNOLOGIES LTD
- Labeler DUNS
- 600634887
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-23
- Public Version
- 1
- Public Version Date
- 2021-05-31
- Public Version Status
- New
- Public Device Record Key
- 56c6d7ba-fb2f-41c9-ac0c-1f83aa396620
Device Description
Package of 30 SU-VEID units (DI# 07290018896037)
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62900 | Invasive-detection multi-parameter physiological monitor, single-use | An electronic device intended for the continuous or intermittent measurement and display of several invasively-detected physiological parameters (e.g., intracranial, compartmental, and blood pressures). It consists of a single unit intended to be used with an invasive access device(s) [e.g., catheter, syringe, needle] (not included) to which it is connected; its use is not dedicated to a specific type of procedure. It typically has proximal and distal connection points for the specific connecting elements, a digital display screen, and controls. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018896136 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993995 | 000 |