FDA UDI
In Commercial Distribution
🇺🇸 United States
Sniffin' Sticks - Odor Quartet
DI: 04260676240209
·
Model: LA-13-00434
·
Burghart Messtechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sniffin' Sticks - Odor Quartet
- Primary DI
- 04260676240209
- Version / Model
- LA-13-00434
- Catalog Number
- LA-13-00434
- Company Name
- Burghart Messtechnik GmbH
- Labeler DUNS
- 341406604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-21
- Public Version
- 1
- Public Version Date
- 2021-04-29
- Public Version Status
- New
- Public Device Record Key
- b132fab6-762a-4587-a3c2-d9e6d9c745e8
Device Description
The Odor Quartet is a training kit consisting of 4 olfactory pens used to improve the sense of smell. The effect of the olfactory training is based both on stimulation of the olfactory mucosa in the nose and on an improvement of sensory impressions in the brain. The Odor Quartet consists of 4 olfactory pens, which release different scents: i.e. lemon, rose, clove and eucalyptus.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| NRK | Kit, Test, Olfactory | Ear, Nose, Throat | 874.1600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65154 | Olfactory test stick | A non-powered, scented device intended to be used to assess a patient’s olfactory function (normosmia, hyposmia, or anosmia). It typically consists of a scented stick(s) intended to be sniffed by the patient, followed by patient description of smell perception. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260676240209 | GS1 |
Customer Contacts
- Phone
- +494103800760
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight