FDA UDI
In Commercial Distribution
🇺🇸 United States
Truepill Inc.
DI: 00850032976114
·
Model: 1
·
Postmeds, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Truepill Inc.
- Primary DI
- 00850032976114
- Version / Model
- 1
- Company Name
- Postmeds, Inc.
- Labeler DUNS
- 080974592
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-19
- Public Version
- 2
- Public Version Date
- 2022-07-20
- Public Version Status
- Update
- Public Device Record Key
- cdc99f1e-4dc1-457c-b1e8-73c609e12091
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35561 | Specimen container mailer, non-insulated | A non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities and is 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 |
| 61935 | Specimen stabilization reagent IVD | A substance or reactant intended to be used alone or in combination with other IVDs to prevent degradation of sensitive analytes (e.g., hormones, proteins, peptides and/or nucleic acids) in a clinical specimen during transportation, storage or processing. A stabilizer is typically a solvent, antioxidant or an enzyme inhibitor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850032976114 | GS1 |