Safe T Check
- Primary DI
- B279S00017
- Brand
- Safe T Check
- Company
- S D I DIAGNOSTICS INC
- Model
- A
- Catalog number
- S0001-7
- Device description
- Safe T Check
- Published
- 2018-10-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| BYP | Mouthpiece, Breathing |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| BYP | Mouthpiece, Breathing | Anesthesiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B279S00017 | Primary | HIBCC | 0 | |
| B279S000173 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Pulmonary function testing kit | A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device. |
Regulatory Flags
- DUNS number
- 037690120
- Device count
- 2000
- 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
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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| 14250892906833 | Vyaire | Vyaire Medical GmbH | BYP | 2025-01-07 |
| 14250892906840 | Vyaire | Vyaire Medical GmbH | BYP | 2025-01-07 |
| 14250892906857 | Vyaire | Vyaire Medical GmbH | BYP | 2025-01-07 |
| 14250892906864 | Vyaire | Vyaire Medical GmbH | BYP | 2025-01-07 |
| 07613365500110 | SpiroDef | Ganshorn Medizin Electronic GmbH | BYP | 2024-12-20 |
| 07613365500134 | SpiroDef | Ganshorn Medizin Electronic GmbH | BYP | 2024-12-20 |
| 07613365500196 | SpiroDef | Ganshorn Medizin Electronic GmbH | BYP | 2024-12-20 |
| 00026072026304 | BF | Allied Medical, LLC | BYP | 2024-10-11 |
| 08052990320219 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | BYP | 2024-09-10 |
| 08052990321179 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | BYP | 2024-09-10 |
| 08052990321834 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | BYP | 2024-09-10 |
| 10197344103737 | MEDLINE | MEDLINE INDUSTRIES, INC. | BYP | 2024-07-22 |
| 00026072026243 | BF | Allied Medical, LLC | BYP | 2024-05-28 |
| 00026072026298 | BF | Allied Medical, LLC | BYP | 2024-05-28 |
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| B279F037020002 | Air Tube | S D I DIAGNOSTICS INC | BYP | 2024-04-08 |
| B279S29807005001 | Air Tube | S D I DIAGNOSTICS INC | BYP | 2024-04-08 |
| B279S29807020002 | Air Tube | S D I DIAGNOSTICS INC | BYP | 2024-04-08 |
| 00817081027686 | Adapter, Tube, Sample Pack | A-M SYSTEMS, LLC | BYP | 2023-11-21 |
| 10384620000730 | InFloCone | ALLIANCE TECH MEDICAL INC | BYP | 2023-09-08 |