FDA UDI
In Commercial Distribution
🇺🇸 United States
Puritan UniTranz-RT
DI: 30609576900076
·
Model: UT-317
·
Puritan Medical Products
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Puritan UniTranz-RT
- Primary DI
- 30609576900076
- Version / Model
- UT-317
- Catalog Number
- UT-317
- Company Name
- Puritan Medical Products
- Labeler DUNS
- 001101419
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- adafa169-f815-4383-ac41-4bbcb196f65c
Device Description
Puritan UniTranz-RT 3ml Filled Vial and 6" Sterile Ultrafine Flock Swab
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LIO | Device, Specimen Collection | Microbiology | 866.2900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33722 | General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50609576900070 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 30609576900076 | GS1 | ||||
| Unit of Use | 00609576900075 | GS1 |
Customer Contacts
- Phone
- 800-321-2313
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -2 – 25 Degrees Celsius