SnapnSeal
- Primary DI
- 00860012637430
- Company
- Medzah Industries
- Model
- EVON102
- Device description
- 3oz/90ml 95kPa Specimen Container, Tamper Evident Seal, EO Sterile, Temperature Slip
- Published
- 2025-03-06
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Regulatory Flags
- DUNS number
- 114193536
- Device count
- 400
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10860012637437 | Primary | GS1 | 0 | |
| 00860012637430 | Unit of Use | GS1 | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| 10860012637437 | Primary | GS1 | 0 | ||||
| 00860012637430 | Unit of Use | GS1 | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| FMH | Container, Specimen, Sterile | 1 | Pathology | 864.3250 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Device Sizes
No records found.
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| 860-288-8696 | info@medzah.com |
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|---|---|---|---|---|
| 10860010472146 | Instant Cold Pack 6inx9in | SAM-1001 | 2025-08-11 | |
| 20860012637410 | Instant Cold Pack 4.75x7 | SAM-3000 | 2025-08-11 | |
| 20860012637427 | Non-Woven Instant Cold Packs 5in x 7.5in | SAM-3001 | 2025-08-11 | |
| 20860011343879 | BIONEX | BNMD01 | 2025-07-30 | |
| 20860011343886 | BIONEX | BNMD02 | 2025-07-30 | |
| 20860011343893 | BIONEX | BNMD03 | 2025-07-30 | |
| 20860011725408 | BIONEX | BNMD04 | 2025-07-30 | |
| 20860011725415 | BIONEX | BNMD05 | 2025-07-30 | |
| 20860011917483 | MEDZAH INSTANT HOT PACK | SAM-2000 | 2025-07-30 | |
| 20860011917490 | MEDZAH INFANT HEEL WARMER | SAM-108 | 2025-07-30 | |
| 20860012637403 | MEDZAH INSTANT HOT PACK | SAM-2001 | 2025-07-30 | |
| 00860009922730 | Medzah Steel Walkers with 5" Wheels | MDZH904SE | 2025-03-07 | |
| 00860009784895 | Ditek Urine Collection Cup | CP10221 | 2025-03-06 | |
| 00850070779050 | MNG 5-Tube CSF Collection | 125218 | 2024-12-03 | |
| 00850070779067 | MNG TRIO Blood Testing | 125220 | 2024-12-03 | |
| 00850070779074 | MNG Single Blood Genetic Test | 125221 | 2024-12-03 | |
| 00850070779081 | MNG Buccal Swab | 125222 | 2024-12-03 | |
| 00850070779098 | MNG Blood Enzymology Testing | 125223 | 2024-12-03 | |
| 00850070779104 | MNG - PTC Collection Kit | 133719 | 2024-12-03 | |
| 00850070779111 | MNG - RNA Sequencing Collection Kit | 138957 | 2024-12-03 |