FDA UDI
In Commercial Distribution
🇺🇸 United States
Compliance EndoKit™
DI: 00840253117007
·
Model: CEK-728
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Compliance EndoKit™
- Primary DI
- 00840253117007
- Version / Model
- CEK-728
- Catalog Number
- CEK-728
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-05
- Public Version
- 3
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 77cf1d3b-9d32-45f8-9045-afb687b8aefb
Device Description
Compliance EndoKit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| MNL | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61950 | Endoscopy preparation kit | A collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device. | No | Active |
| 45673 | Endoscope cleaning kit | A collection of devices and supplies intended for performing manual cleaning of endoscopes. Items include brushes of several sizes, detergents, and applicators. This manual cleaning is typically performed before endoscope sterilization. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840253113405 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00840253117007 | GS1 |