FDA UDI
In Commercial Distribution
🇺🇸 United States
SnapnSeal
DI: 10860010472139
·
Model: EVON101
·
Medzah Industries
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
400
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Basic Information
- Brand Name
- SnapnSeal
- Primary DI
- 10860010472139
- Version / Model
- EVON101
- Company Name
- Medzah Industries
- Labeler DUNS
- 114193536
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 400
- Record Status
- Published
- Publish Date
- 2023-11-09
- Public Version
- 1
- Public Version Date
- 2023-11-17
- Public Version Status
- New
- Public Device Record Key
- dddd9bbc-892c-4f2a-ab13-510a14c254bf
Device Description
3oz/90ml 95kpa Specimen Container, Tamper Evident Seal, EO Sterile
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMH | Container, Specimen, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58177 | Urine specimen collection kit IVD | A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00086001047213 | GS1 | ||||
| Primary | 10860010472139 | GS1 |
Customer Contacts
- Phone
- 860-288-8696
- [email protected]