Standard Breathing Circuit with Face Mask - Toddler
- Primary DI
- 68697645010040
- Brand
- Standard Breathing Circuit with Face Mask - Toddler
- Company
- MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
- Model
- BC21087
- Device description
- An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
- Published
- 2023-06-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 68697645010040 | Package | GS1 | 40 | In Commercial Distribution |
| 08697645010048 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 68697645010040 | 68697645010040 | |
| 08697645010048 | 08697645010048 | 8697645010048 |
GMDN Terms#
| Term | Definition |
|---|---|
| Ventilator breathing circuit, single-use | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Humidity | 15 Percent (%) Relative Humidity | 70 Percent (%) Relative Humidity | |
| Storage Environment Temperature | 5 Degrees Celsius | 40 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 565424848
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
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| M4853116117 | HME with Flex Tubes | 31161 | 2025-07-09 | |
| 10850014574649 | Bacterial Viral Filter | BV001 | 2025-07-09 | |
| 10850014574656 | Bacterial Viral Filter | BV002 | 2025-07-09 | |
| 10850014574694 | Heat Moisture Exchanger with Filter | HME712 | 2025-07-09 | |
| 10850014574663 | Bacterial Viral Filter | BV001 | 2025-07-09 | |
| 10850014574670 | Bacterial Viral Filter | BV002 | 2025-07-09 | |
| 10850014574687 | Heat Moisture Exchanger with Filter | HME712 | 2025-07-09 | |
| M4853116128 | HME with Flex Tubes | 31161 | 2025-07-09 | |
| M485AL08021V0011 | Bacterial-Viral HME Filter | AL-08021.V001 | 2023-08-10 | |
| M485AL1100V0021 | Breathing Circuit, Adult Corrugated | AL-1100.V002 | 2023-08-10 | |
| M485AL1400V0051 | Breathing Circuit, Pediatric, Corrugated | AL-1400.V005 | 2023-08-10 | |
| M485AL08021V0012 | Bacterial-Viral HME Filter | AL-08021.V001 | 2023-08-10 | |
| M485AL1100V0022 | Breathing Circuit, Adult Corrugated | AL-1100.V002 | 2023-08-10 | |
| M485AL1400V0052 | Breathing Circuit, Pediatric, Corrugated | AL-1400.V005 | 2023-08-10 | |
| 08697645010048 | Standard Breathing Circuit with Face Mask - Toddler | BC21087 | 2023-06-30 | |
| 08697645010079 | Standard Breathing Circuit with Mouthpiece | BC21273 | 2023-06-30 | |
| 08697645010116 | Standard Breathing Circuit with Face Mask - Adult Medium | BC21089 | 2023-06-30 | |
| 08697645010550 | Standard Breathing Circuit with Trach | BC21090 | 2023-06-30 | |
| 08697645010055 | Standard Breathing Circuit with Face Mask - Child/Adult Small | BC21088 | 2023-06-30 | |
| 08697645010062 | Standard Breathing Circuit with Mouthpiece | BC21092 | 2023-06-30 |
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