Safe T Check
by Sdi Diagnostics, Inc. 2 variants
Safe T Check (S0001-7) is a pulmonary function testing kit (FDA Class I; FDA product code BYP, Mouthpiece, Breathing) made by Sdi Diagnostics, Inc., listed in FDA GUDID since 30 Oct 2018 (UDI-DI B279S00017), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB279S00017 | Date30 Oct 2018 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Pulmonary function testing kit
- Model / Ref / Catalog
- A, S0001-7
- Primary DI / UDI-DI
- B279S00017
- FDA product code
- BYP
- GMDN term
- Pulmonary function testing kit
- Device class
- Class I
- Regulation number
- 868.5620
- GUDID distribution status
- In Commercial Distribution
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