FDA UDI
In Commercial Distribution
🇺🇸 United States
22MM FLEXTUBE BS WITH 3L BAG LUER ELBOW MONITORING LINE ANAES FACE MASK AND HMEF
DI: 05030267160242
·
Model: 2010235
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 22MM FLEXTUBE BS WITH 3L BAG LUER ELBOW MONITORING LINE ANAES FACE MASK AND HMEF
- Primary DI
- 05030267160242
- Version / Model
- 2010235
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-14
- Public Version
- 3
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 4774aa04-5cab-471d-8a67-a019229e05bb
Device Description
22MM FLEXTUBE BREATHING SYSTEM WITH 3L BAG, LUER ELBOW, MONITORING LINE, ANAESTHETIC FACE MASK AND HMEF 1.6M
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 |
|---|---|---|---|---|
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | Anesthesiology | 868.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37704 | Anaesthesia breathing circuit, single-use | An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05030267160259 | GS1 | 8 | In Commercial Distribution | ||
| Primary | 05030267160242 | GS1 |
Customer Contacts
- Phone
- 3154512900
- [email protected]