FDA UDI
In Commercial Distribution
🇺🇸 United States
DUALGUARD ADULT 10FT LINE WITH SLIP LUER FILTER
DI: 05055788714644
·
Model: 032-10-868U
·
FLEXICARE MEDICAL LIMITED
Product Codes
3
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DUALGUARD ADULT 10FT LINE WITH SLIP LUER FILTER
- Primary DI
- 05055788714644
- Version / Model
- 032-10-868U
- Company Name
- FLEXICARE MEDICAL LIMITED
- Labeler DUNS
- 504406273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-04
- Public Version
- 5
- Public Version Date
- 2024-12-30
- Public Version Status
- Update
- Public Device Record Key
- 6df4b753-6595-4537-9d1c-74b2e72566c4
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| MNK | Endoscopic Bite Block | Gastroenterology, Urology | 876.1500 | 1 |
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | 868.5340 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10405 | Seizure bite block | A non-sterile device inserted into a patient's mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) typically when the patient has convulsions (a seizure) or is undergoing an electroconvulsive therapy (ECT) that will cause nausea or can cause him/her to bite their jaws together. It will also secure a free flow for air and vomit. This is a single-use device. | No | Active |
| 35201 | Nasal oxygen cannula, basic | A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device. | No | Active |
| 36306 | Nasal oxygen cannula, carbon-dioxide-sampling | A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055788714644 | GS1 |