FDA UDI
In Commercial Distribution
🇺🇸 United States
Thermo Scientific Protocol™ Parasitology System
DI: 00845275005103
·
Model: 23-005-47
·
Fisher Diagnostics
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Thermo Scientific Protocol™ Parasitology System
- Primary DI
- 00845275005103
- Version / Model
- 23-005-47
- Company Name
- Fisher Diagnostics
- Labeler DUNS
- 183998769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4801fcc8-63e3-44d1-ae9d-706eaa8b0d79
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
- 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 |
|---|---|---|---|---|
| KDT | Container, Specimen Mailer And Storage, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57931 | Carey-Blair transport medium specimen collection kit | A sterile specimen swab with a transport container containing liquid Carey-Blair transport medium intended to be used for the collection, preservation, and transport of a clinical specimen suspected of containing microorganisms for culture, analysis, and/or other investigation. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845275005103 | GS1 | ||||
| Unit of Use | 00845275006476 | GS1 |
Customer Contacts
- Phone
- 800-528-0494
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius