FDA UDI
In Commercial Distribution
🇺🇸 United States
MedStream
DI: 00842472106855
·
Model: KIT-OIS
·
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MedStream
- Primary DI
- 00842472106855
- Version / Model
- KIT-OIS
- Catalog Number
- KIT-OIS
- Company Name
- MEDICAL SPECIALTIES DISTRIBUTORS, LLC
- Labeler DUNS
- 153608369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-08
- Public Version
- 1
- Public Version Date
- 2018-11-08
- Public Version Status
- New
- Public Device Record Key
- 6a73627c-e30f-4bde-ab25-1cb02650eb3a
Device Description
KIT-OIS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| PXG | Spill Kit | General Hospital | 880.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61937 | Shoe cover, non-conductive, sterile | A sterile device made of a non-conductive, non-woven synthetic fabric materials intended to be worn over the shoes of healthcare staff typically during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10842472106852 | GS1 | 30 | In Commercial Distribution | ||
| Primary | 00842472106855 | GS1 |
Customer Contacts
- Phone
- 800-967-6400
- [email protected]