Diversatek Healthcare
Endoscopy Basic Procedure Kit w/ Combination Endoscope Cleaning Brush & Suction Tubing
2manufacturers in China registered for this device type
65catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Diversatek Healthcare Inc, United States |
|---|---|
| FDA product code | FCH |
| Device type | Tray, Biopsy, Without Biopsy Instruments |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-20 |
| Record revised | 2023-06-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, box of 20, case of 5, case of 24, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1201-56 | In distribution | |
| 1201-84 | In distribution | |
| 1201-105 | In distribution | |
| 1201-66 | In distribution | |
| 1201-81 | In distribution | |
| 1201-102 | In distribution | |
| 1201-50 | In distribution | |
| 1201-94 | In distribution | |
| 1201-75 | In distribution | |
| 1201-76 | In distribution | |
| 1201-57 | In distribution | |
| 1201-88 | In distribution | |
| 1201-112 | In distribution | |
| 1201-79 | In distribution | |
| 1201-107 | In distribution | |
| 1201-58 | In distribution | |
| 1201-115 | In distribution | |
| 1201-67 | In distribution | |
| 1201-110 | In distribution | |
| 1201-54 | In distribution | |
| 1201-96 | In distribution | |
| 1201-47 | In distribution | |
| 1201-59 | In distribution | |
| 1201-89 | In distribution | |
| 1201-53 | In distribution | |
| 1201-100 | In distribution | |
| 1201-69 | In distribution | |
| 1201-83 | In distribution | |
| 1201-99 | In distribution | |
| 1201-106 | In distribution | |
| 1201-108 | In distribution | |
| 1201-63 | In distribution | |
| 1201-62 | In distribution | |
| 1201-117 | In distribution | |
| 1201-73 | In distribution | |
| 1201-65 | In distribution | |
| 1201-74 | In distribution | |
| 1201-86 | In distribution | |
| 1201-46 | In distribution | |
| 1201-49 | In distribution | |
| 1201-72 | In distribution | |
| 1201-103 | In distribution | |
| 1201-70 | In distribution | |
| 1201-60 | In distribution | |
| 1201-71 | In distribution | |
| 1201-55 | In distribution | |
| 1201-93 | In distribution | |
| 1201-77 | In distribution | |
| 1201-68 | In distribution | |
| 1201-113 | In distribution | |
| 1201-51 | In distribution | |
| 1201-78 | In distribution | |
| 1201-85 | In distribution | |
| 1201-87 | In distribution | |
| 1201-52 | In distribution | |
| 1201-98 | In distribution | |
| 1201-95 | In distribution | |
| 1201-61 | In distribution | |
| 1201-101 | In distribution | |
| 1201-80 | In distribution | |
| 1201-64 | In distribution | |
| 1201-48 | In distribution | |
| 1201-92 | In distribution | |
| 1201-116 | In distribution | |
| 1201-97 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ACS | American Contract Systems, Inc. | 86 |
| Medline Industries, Inc. | Medline Industries, Inc. | 59 |
| Therapak | Therapak, LLC | 12 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 5 |
| Medichoice | Owens & Minor Distribution, Inc. | 1 |
| CleanFreak® | Diversatek Healthcare Inc | 1 |
| Halyard | Avid Medical, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.