FDA UDI
In Commercial Distribution
🇺🇸 United States
Para-Pak SAF/C&S
DI: 00840733102943
·
Model: 300412
·
MERIDIAN BIOSCIENCE, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Para-Pak SAF/C&S
- Primary DI
- 00840733102943
- Version / Model
- 300412
- Catalog Number
- 300412
- Company Name
- MERIDIAN BIOSCIENCE, INC.
- Labeler DUNS
- 092815364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-10
- Public Version
- 2
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 20077a87-9f7b-4cdf-8f04-32185d6eef19
Device Description
Para-Pak systems are convenient systems for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. It is designed for easy use by individuals not trained in microbiological techniques and affords an excellent means of minimizing the adverse effects of delay in specimen transport.
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IGG | Formaldehyde (Formalin, Formol) | Pathology | 864.4010 | 1 |
| JSM | Culture Media, Non-Propagating Transport | Microbiology | 866.2390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57910 | Faecal specimen container IVD, fixative | A covered plastic receptacle containing a fixative solution [e.g., sodium acetate, acetic acid and/or formaldehyde (SAF), Schaudinn’s, polyvinyl alcohol (PVA) or acid alcohol] intended to be used for the collection, and preservation and/or transport, of a faecal specimen for analysis and/or other investigation [e.g., evaluation for the presence of intestinal parasites and/or their eggs (ova)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840733102943 | GS1 |
Customer Contacts
- Phone
- 513-343-3858
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius