FDA UDI
In Commercial Distribution
🇺🇸 United States
US Paramed Collection Oral Fluid Kit
DI: 00850054552044
·
Model: Exempt
·
Quest Diagnostics
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- US Paramed Collection Oral Fluid Kit
- Primary DI
- 00850054552044
- Version / Model
- Exempt
- Company Name
- Quest Diagnostics
- Labeler DUNS
- 189222334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-01
- Public Version
- 1
- Public Version Date
- 2024-05-09
- Public Version Status
- New
- Public Device Record Key
- 82177368-ce9b-40cf-a00c-43747bde395f
Device Description
US Paramed Collection Oral Fluid 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDT | Container, Specimen Mailer And Storage, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15743 | Specimen container mailer, insulated | A non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection and insulation for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities. It includes insulation intended to provide a thermal barrier between the specimen and the environment to preserve temperature-sensitive samples. The device is also intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850054552041 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00850054552044 | GS1 |