FDA UDI
In Commercial Distribution
🇺🇸 United States
Batrik Your First Check
DI: 00690521015012
·
Model: 17-222
·
Batrik Medical Manufacturing Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Batrik Your First Check
- Primary DI
- 00690521015012
- Version / Model
- 17-222
- Catalog Number
- 17-222
- Company Name
- Batrik Medical Manufacturing Inc
- Labeler DUNS
- 243880700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-11
- Public Version
- 2
- Public Version Date
- 2025-07-22
- Public Version Status
- Update
- Public Device Record Key
- ebc3f7fe-6bc0-487c-b09c-a793b604fcd4
Device Description
Pre-Treated Flat sponge (Enzymatic). Comes in a freestanding pouch which can be used as a basin. Simply add up to 500 mL of water (Enzymatic).
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
- Yes
- 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 |
|---|---|---|---|---|
| 63385 | Medical device cleaning agent | A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00690521015876 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 00690521015012 | GS1 | ||||
| Package | 00690521015111 | GS1 | Case | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 514-631-7988
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight