FDA UDI
In Commercial Distribution
🇺🇸 United States
PARALLEL Y-PIECE, 22MM
DI: 05030267056347
·
Model: 1926000
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PARALLEL Y-PIECE, 22MM
- Primary DI
- 05030267056347
- Version / Model
- 1926000
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-12
- Public Version
- 2
- Public Version Date
- 2022-02-07
- Public Version Status
- Update
- Public Device Record Key
- 72dcb134-7787-42ca-b5c1-c8a7e4f85b2e
Device Description
PARALLEL Y-PIECE, 22MM
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| BZA | Connector, Airway (Extension) | Anesthesiology | 868.5810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43435 | Y-piece breathing circuit connector, single-use | 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 typically made of light plastic. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05030267004102 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 05030267056347 | GS1 | ||||
| Package | 05030267004119 | GS1 | 80 | In Commercial Distribution |
Customer Contacts
- Phone
- 3154512900
- [email protected]