FDA UDI
In Commercial Distribution
🇺🇸 United States
BIO-GUARD STARTER PACK (32 POUCHES)
DI: D248B20021
·
Model: B2002
·
HAGER WORLDWIDE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
32
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Basic Information
- Brand Name
- BIO-GUARD STARTER PACK (32 POUCHES)
- Primary DI
- D248B20021
- Version / Model
- B2002
- Company Name
- HAGER WORLDWIDE, INC.
- Labeler DUNS
- 009277971
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 32
- Record Status
- Published
- Publish Date
- 2023-08-16
- Public Version
- 1
- Public Version Date
- 2023-08-24
- Public Version Status
- New
- Public Device Record Key
- 3f43ac3d-d268-464a-a17e-a28e5945a79c
Device Description
Dental evacuation line cleaner
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
- No
- 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 |
|---|---|---|---|---|
| LRJ | Disinfectant, medical devices | General Hospital | 880.6890 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | D248B20000 | HIBCC | ||||
| Primary | D248B20021 | HIBCC |
Customer Contacts
- Phone
- +1(828)624-3319
- [email protected]