FDA UDI
In Commercial Distribution
🇺🇸 United States
FLEXIBLE FIXED ELBOW PAEDIATRIC/NEONATAL CATHETER MOUNT, 15M - 7.6MM PORT - 15F
DI: 05030267066353
·
Model: 3532000
·
Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- FLEXIBLE FIXED ELBOW PAEDIATRIC/NEONATAL CATHETER MOUNT, 15M - 7.6MM PORT - 15F
- Primary DI
- 05030267066353
- Version / Model
- 3532000
- Company Name
- Intersurgical Incorporated
- Labeler DUNS
- 785952607
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-15
- Public Version
- 3
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- ddeac372-cc79-47fc-adb3-9dc0b06a7a94
Device Description
FLEXIBLE FIXED ELBOW PAEDIATRIC/NEONATAL CATHETER MOUNT, 15M - 7.6MM PORT - 15F, 100MM
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 |
|---|---|---|---|---|
| 42476 | Breathing circuit catheter mount, single-use | A device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end; it may include an integrated suction port or be provided with a microbial medical gas filter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05030267019199 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 05030267066353 | GS1 | ||||
| Package | 05030267019182 | GS1 | 25 | In Commercial Distribution |