FDA UDI
In Commercial Distribution
🇺🇸 United States
SmartPractice
DI: 00854498007474
·
Model: AL1701S25
·
Smarthealth, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- SmartPractice
- Primary DI
- 00854498007474
- Version / Model
- AL1701S25
- Catalog Number
- AL1701S25
- Company Name
- Smarthealth, Inc.
- Labeler DUNS
- 061081477
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2020-12-09
- Public Version
- 2
- Public Version Date
- 2022-03-03
- Public Version Status
- Update
- Public Device Record Key
- 8cb58946-1904-40a3-9867-d59168e9b4e2
Device Description
patchProtect, 25 sheets, Small
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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34832 | Waterproof skin adhesive tape | A long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854498007474 | GS1 | ||||
| Unit of Use | 10854498007471 | GS1 |
Customer Contacts
- Phone
- 1-800-878-3837
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Keep dry.