FDA UDI
In Commercial Distribution
🇺🇸 United States
MedStream
DI: 00842472100839
·
Model: MS990
·
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MedStream
- Primary DI
- 00842472100839
- Version / Model
- MS990
- Catalog Number
- MS990
- Company Name
- MEDICAL SPECIALTIES DISTRIBUTORS, LLC
- Labeler DUNS
- 153608369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9d2ae226-5b6d-4891-a495-4e29a4130936
Device Description
VIAL ACCESS SPIKE CLAVE® MULTIDOSE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58510 | Vial transfer spike | A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial’s sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial’s contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10842472100836 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00842472100839 | GS1 |
Customer Contacts
- Phone
- 800-967-6400
- [email protected]