FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Specimen Collection Swab
DI: 00810050851848
·
Model: SW0201
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Specimen Collection Swab
- Primary DI
- 00810050851848
- Version / Model
- SW0201
- Catalog Number
- SW0201
- Company Name
- TYPENEX MEDICAL LLC
- Labeler DUNS
- 600850213
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-01
- Public Version
- 5
- Public Version Date
- 2024-01-01
- Public Version Status
- Update
- Public Device Record Key
- ce66ce34-9522-4583-b26f-e3d344b16c87
- Distribution End Date
- 2023-12-31
Device Description
Specimen Collection Swab - Oropharyngeal
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57940 | Oral/upper respiratory tract specimen collection swab | A piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for culture, analysis, and/or other investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810050851862 | GS1 | Case | 200 | Not in Commercial Distribution | 2023-12-31 |
| Primary | 00810050851848 | GS1 | ||||
| Package | 10810050851869 | GS1 | Master Carton | 20 | Not in Commercial Distribution | 2023-12-31 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 151 | Millimeter |