FDA UDI
In Commercial Distribution
🇺🇸 United States
Medical Action Industries
DI: 20809160002527
·
Model: SM840
·
MEDICAL ACTION INDUSTRIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
Basic Information
- Brand Name
- Medical Action Industries
- Primary DI
- 20809160002527
- Version / Model
- SM840
- Company Name
- MEDICAL ACTION INDUSTRIES INC.
- Labeler DUNS
- 092364462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2016-08-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c23692cc-1c43-4110-aeee-128ea1166ba9
Device Description
Ind: Steam Sbw 4000/Cs
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LRT | INDICATOR, STERILIZATION | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13732 | Biological sterilization indicator | A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30809160002524 | GS1 | 16 | In Commercial Distribution | ||
| Primary | 20809160002527 | GS1 | ||||
| Unit of Use | 10809160002520 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951113 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- store at room temperature
- Type
- Special Storage Condition, Specify