FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sterile Specimen Container
DI: 17503025060146
·
Model: 070001
·
Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Sterile Specimen Container
- Primary DI
- 17503025060146
- Version / Model
- 070001
- Company Name
- Thermo Fisher Scientific (Monterrey), S. de R.L. de C.V.
- Labeler DUNS
- 813622313
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-09
- Public Version
- 2
- Public Version Date
- 2022-08-09
- Public Version Status
- Update
- Public Device Record Key
- 4be3a9d8-4eac-45b7-8fa4-bb15e35631ef
- Distribution End Date
- 2022-07-28
Device Description
90ml MIDSTREAM KITw/FUNNEL ST
Device Characteristics
- Single Use
- No
- 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
- 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
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMH | CONTAINER, SPECIMEN, STERILE | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47775 | General specimen container IVD, no additive/medium | An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37503025060140 | GS1 | PACKAGE | 1 | Not in Commercial Distribution | 2022-07-28 |
| Primary | 17503025060146 | GS1 | ||||
| Package | 57503025060144 | GS1 | Case | 50 | Not in Commercial Distribution | 2022-07-28 |