FDA UDI
In Commercial Distribution
🇺🇸 United States
Sniffin' Sticks - Screening 12 Test Refill Set
DI: 04260676240155
·
Model: LA-13-00437
·
Burghart Messtechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sniffin' Sticks - Screening 12 Test Refill Set
- Primary DI
- 04260676240155
- Version / Model
- LA-13-00437
- Catalog Number
- LA-13-00437
- 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
- 966f10ba-4b71-46b2-a3be-8b17e38a5573
Device Description
The Screening 12 Test is intended to be used for examination of smell disorders on humans. The test result can be used to differentiate between Normosmia, Hyposmia, and Anosmia, if the patient is cooperative.
Device Characteristics
- Single Use
- Yes
- 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 | 04260676240155 | GS1 |
Customer Contacts
- Phone
- +4941038007619
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius