FDA UDI
In Commercial Distribution
🇺🇸 United States
PENTAX
DI: 04961333073009
·
Model: OF-B75
·
HOYA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PENTAX
- Primary DI
- 04961333073009
- Version / Model
- OF-B75
- Company Name
- HOYA CORPORATION
- Labeler DUNS
- 691519705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-07
- Public Version
- 8
- Public Version Date
- 2025-04-07
- Public Version Status
- Update
- Public Device Record Key
- 0f851ce0-969b-45f1-9565-67bdb89f206c
Device Description
Suction Channel Cleaning & Disinfection Adapter
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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
- Yes
- Sterilization Methods
- High-level Disinfectant, Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | Ear, Nose, Throat | 874.4680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64509 | Endoscope leak tester tubing | A length of flexible tube with connectors intended to deliver a medium (typically air) from a leak tester to the interior of an endoscope during a leak test; it may in addition be intended for other endoscope pre- or post-procedural processing (e.g., allow connection of a fluid seal). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333073009 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023376 | 000 |