FDA UDI
In Commercial Distribution
🇺🇸 United States
BE 127 Wye Connector
DI: M996BE1270
·
Model: BE 127
·
INSTRUMENTATION INDUSTRIES, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BE 127 Wye Connector
- Primary DI
- M996BE1270
- Version / Model
- BE 127
- Catalog Number
- BE 127
- Company Name
- INSTRUMENTATION INDUSTRIES, INCORPORATED
- Labeler DUNS
- 053146767
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-11
- Public Version
- 1
- Public Version Date
- 2019-05-20
- Public Version Status
- New
- Public Device Record Key
- 4992617c-1358-48ed-b3ab-061242bce12a
Device Description
BE 127 Wye Connector with (2) 22mm OD ports and (1) 15mm ID/22mm OD port. Fits components of adult ventilator circuits. Reusable.
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
- Ethylene Oxide, High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | 868.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43954 | Y-piece breathing circuit connector, reusable | A connecting device shaped in the form of a "Y" and designed to connect compatible components [e.g., the tubing and face mask or an endotracheal (ET) tube] to create a breathing circuit. In order to function this device will be part of a breathing circuit and will typically connect the inspiratory and expiratory sides at the point of entry into the patient. It will typically be used during anaesthesia and/or ventilation and is made of durable materials, e.g., plastic and/or metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M996BE1272 | HIBCC | Ziplock bag | 10 | In Commercial Distribution | |
| Primary | M996BE1270 | HIBCC |
Customer Contacts
- Phone
- 412-854-1133
- [email protected]