Identity
- Trade Name
- SUGAR, DEXTROSE (GLUCOSE), 75 GM PACKET FDA UDI
- Generic Name
- Breath specimen container IVD FDA UDI
- Model / Reference
- QT02300-75-S FDA UDI
Identifiers
- Catalog Number
- QT02300-75-S FDA UDI
- Primary DI / UDI-DI
- 00850010197142 FDA UDI
- FDA Product Code
- NNI FDA UDI
- GMDN Term
- Breath specimen container IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breath specimen container IVD
SUGAR, DEXTROSE (GLUCOSE), 75 GM PACKET is a single-use, implantable breath specimen container used for the collection of respiratory specimens. This device is designed to contain a portion of an exhaled breath sample and is intended for the analysis of volatile organic compounds in the specimen.
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Also classified as Breath specimen container IVD.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Quintron Instrument Co. Inc.
Sources (1)
- FDA UDI c4e9238f-6ddc-4a9c-bb42-8a8f03aff1dd 33 fields · synced Jun 28, 2026