FDA UDI
In Commercial Distribution
🇺🇸 United States
BE 105-40 Pressure Adapter
DI: M996BE105400
·
Model: BE 105-40
·
INSTRUMENTATION INDUSTRIES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BE 105-40 Pressure Adapter
- Primary DI
- M996BE105400
- Version / Model
- BE 105-40
- Catalog Number
- BE 105-40
- Company Name
- INSTRUMENTATION INDUSTRIES, INCORPORATED
- Labeler DUNS
- 053146767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-17
- Public Version
- 1
- Public Version Date
- 2018-10-18
- Public Version Status
- New
- Public Device Record Key
- 418730fd-d5b0-4b9c-9d66-99f8d54dbdca
Device Description
The BE 105-40 Pressure Adapter: Dimensions - Barbed port fits 3/16" I.D. tubing, x 15mm I.D./22mm O.D. x 15mm I.D./22mm O.D. Barbed port is capped with a silicone rubber cap.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61621 | Breathing circuit pressure detection port plug | A non-sterile device designed to seal the port of a breathing circuit pressure detection adaptor/connector (e.g., Y-piece) when the port is not needed for pressure monitoring. It is typically a small Luer cap made of plastic (e.g., polysulphone). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M996BE105400 | HIBCC |
Customer Contacts
- Phone
- 412-854-1133
- [email protected]