FDA UDI
In Commercial Distribution
🇺🇸 United States
SmartPractice
DI: 00854498007153
·
Model: AL7001
·
Smarthealth, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- SmartPractice
- Primary DI
- 00854498007153
- Version / Model
- AL7001
- Catalog Number
- AL7001
- Company Name
- Smarthealth, Inc.
- Labeler DUNS
- 061081477
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2020-12-02
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 27e50196-58e6-4742-824d-abe9f3d43535
Device Description
Finn Chambers on Scanpor 8mm, 100x10, 100/box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LDH | System, Delivery, Allergen And Vaccine |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58299 | Allergy testing adhesive strip, epicutaneous | A band of adhesive material designed to be used for epicutaneous allergy testing. The device typically consists of a central portion containing a series of transparent discs onto which are applied potentially allergenic substances; it includes on one side a hypoallergenic pressure-sensitive adhesive for application to the skin of the patient. The device may include additional strips that can be used for labelling, to aid diagnosis of skin reactions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10854498007150 | GS1 | ||||
| Primary | 00854498007153 | GS1 |
Customer Contacts
- Phone
- 1-800-878-3837
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013820 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Keep dry.