FDA UDI
In Commercial Distribution
🇺🇸 United States
SED-CONNECT
DI: M445693ASAMPLE1
·
Model: 693A-Sample
·
MEDICAL CHEMICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- SED-CONNECT
- Primary DI
- M445693ASAMPLE1
- Version / Model
- 693A-Sample
- Catalog Number
- 693A-Sample
- Company Name
- MEDICAL CHEMICAL CORPORATION
- Labeler DUNS
- 008496861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2021-07-08
- Public Version Status
- Update
- Public Device Record Key
- ec1a4aa8-708c-4e17-ba41-133483b6a332
Device Description
SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This kit contains 10 sets of single use components.
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 |
|---|---|---|---|---|
| LKS | Device, Parasite Concentration | Microbiology | 866.2900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57939 | Faecal parasite specimen concentration kit IVD | A collection of devices intended to be used for the concentration and recovery of eggs, larvae, and cysts of intestinal parasites (e.g., pinworms) from a faecal specimen, for microscopic analysis and/or other investigation. The kit typically includes reagents, centrifuge tubes, and filters. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M445693ASAMPLE1 | HIBCC | ||||
| Unit of Use | M445693ASAMPLE0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K941129 | 000 |