FDA UDI
In Commercial Distribution
🇺🇸 United States
SAM Chest Seal
DI: 00822045000186
·
Model: CS202-EN
·
SAM Medical Products
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SAM Chest Seal
- Primary DI
- 00822045000186
- Version / Model
- CS202-EN
- Company Name
- SAM Medical Products
- Labeler DUNS
- 131084188
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-01
- Public Version
- 1
- Public Version Date
- 2022-09-09
- Public Version Status
- New
- Public Device Record Key
- 7c688620-89be-4387-b60d-1ff4f4da252d
Device Description
SAM Chest Seal Valved 2.0
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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46424 | Pneumothorax dressing | A sterile covering applied to a chest wound that has penetrated the pleura (serous membrane covering the lungs and lining the pleural cavity) in order to temporarily treat and prevent pneumothorax (collapsed lung). The device may be self-adhesive and have a one-way valve that enables internal pressure release while preventing air entry. It is typically used by first responders [emergency medical services (EMS)] in the management of penetrating chest trauma (e.g., bullet or stab wounds). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10822045000183 | GS1 | Case | 25 | In Commercial Distribution | |
| Primary | 00822045000186 | GS1 |
Customer Contacts
- Phone
- 5036395474
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102403 | 000 |