FDA UDI
In Commercial Distribution
🇺🇸 United States
OSOM Ultra Flu Aspirate 25T Kit
DI: 00742860100239
·
Model: 1007
·
SEKISUI DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- OSOM Ultra Flu Aspirate 25T Kit
- Primary DI
- 00742860100239
- Version / Model
- 1007
- Catalog Number
- 1007
- Company Name
- SEKISUI DIAGNOSTICS, LLC
- Labeler DUNS
- 966812344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2017-01-10
- Public Version
- 4
- Public Version Date
- 2021-01-22
- Public Version Status
- Update
- Public Device Record Key
- 7b29495a-85cd-4cdd-9ede-f0df1133dd4a
Device Description
OSOM Ultra Flu Aspirate 25T Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PSZ | Devices detecting influenza A, B, and C virus antigens | Microbiology | 866.3328 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57954 | Nasopharyngeal aspirate container IVD | A covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a nasopharyngeal aspirate specimen for culture, analysis, and/or other investigation. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00742860100239 | GS1 | ||||
| Unit of Use | 10742860100236 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius