FDA UDI
In Commercial Distribution
🇺🇸 United States
MR Patient Care LoFlo CO2 with Airway Adapters (100)
DI: 20884838037834
·
Model: LoFlo Line Adu Airway Adpt, Box 100
·
Philips Ds North America LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- MR Patient Care LoFlo CO2 with Airway Adapters (100)
- Primary DI
- 20884838037834
- Version / Model
- LoFlo Line Adu Airway Adpt, Box 100
- Catalog Number
- 989803185381
- Company Name
- Philips Ds North America LLC
- Labeler DUNS
- 013649151
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-12-26
- Public Version
- 8
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 7ed11cae-2587-41f8-b58f-5e5d85f2e8c5
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Anesthesiology | 868.1400 | 2 |
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 | 20884838037834 | GS1 | ||||
| Unit of Use | 00884838037830 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]