FDA UDI
In Commercial Distribution
🇺🇸 United States
VIVIT Supply
DI: 10810141931401
·
Model: 20121
·
Vivit Supply LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
300
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Basic Information
- Brand Name
- VIVIT Supply
- Primary DI
- 10810141931401
- Version / Model
- 20121
- Company Name
- Vivit Supply LLC
- Labeler DUNS
- 119042597
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 300
- Record Status
- Published
- Publish Date
- 2024-03-26
- Public Version
- 1
- Public Version Date
- 2024-04-03
- Public Version Status
- New
- Public Device Record Key
- b7ddd3ee-6f4d-4b8c-9cfd-cf03457d4e9d
Device Description
Commend Nitrile Exam Glove, Chemo Drug Tested, Textured Fingertips, Powder-Free,
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZA | Polymer Patient Examination Glove | General Hospital | 880.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66499 | Total immunoglobulin E (IgE total) IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total immunoglobulin E (IgE total) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20810141931408 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 10810141931401 | GS1 | ||||
| Unit of Use | 00810141931404 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry, and well ventilated space out of direct sunlight.