FDA UDI
In Commercial Distribution
🇺🇸 United States
Seer Home
DI: 09355751001105
·
Model: SM-01-9008
·
SEER MEDICAL HOLDINGS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- Seer Home
- Primary DI
- 09355751001105
- Version / Model
- SM-01-9008
- Company Name
- SEER MEDICAL HOLDINGS LIMITED
- Labeler DUNS
- 744473197
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2023-09-14
- Public Version
- 1
- Public Version Date
- 2023-09-22
- Public Version Status
- New
- Public Device Record Key
- 0e2e13d3-bfe1-4166-be4c-762e70e563d8
Device Description
WaterTabs Pack
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
- 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 |
|---|---|---|---|---|
| 10035 | Skin surface device adhesive | A substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09355751001105 | GS1 | ||||
| Unit of Use | 09355751001143 | GS1 |