FDA UDI
In Commercial Distribution
🇺🇸 United States
NON-STERILE Biopsy Valve Covers
DI: 00690521020672
·
Model: 16-0022
·
Batrik Medical Manufacturing Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NON-STERILE Biopsy Valve Covers
- Primary DI
- 00690521020672
- Version / Model
- 16-0022
- Catalog Number
- 16-0022
- Company Name
- Batrik Medical Manufacturing Inc
- Labeler DUNS
- 243880700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-08
- Public Version
- 1
- Public Version Date
- 2024-10-16
- Public Version Status
- New
- Public Device Record Key
- b5d857dc-266d-444c-b42c-0c7cd3e024f5
Device Description
Biopsy Valve Cover - Olympus & Fujinon - Blue
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62145 | Endoscope working-channel valve, single-use | A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690521020672 | GS1 |
Customer Contacts
- Phone
- 5146317988
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from direct sunlight