FDA UDI
In Commercial Distribution
🇺🇸 United States
Flexi-Lock Catheter Mount 15mm with 15mm M and 15mm F Connectors
DI: 05055788768562
·
Model: 038-61-310U
·
FLEXICARE MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Flexi-Lock Catheter Mount 15mm with 15mm M and 15mm F Connectors
- Primary DI
- 05055788768562
- Version / Model
- 038-61-310U
- Company Name
- FLEXICARE MEDICAL LIMITED
- Labeler DUNS
- 504406273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-28
- Public Version
- 3
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 99ebd8aa-1a0b-450f-a03a-c05c1be9c157
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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 |
|---|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | 868.5240 | 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 |
|---|---|---|---|---|---|---|
| Primary | 05055788768562 | GS1 |