FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MedStream
DI: 00842472103014
·
Model: MSB1500
·
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MedStream
- Primary DI
- 00842472103014
- Version / Model
- MSB1500
- Catalog Number
- MSB1500
- Company Name
- MEDICAL SPECIALTIES DISTRIBUTORS, LLC
- Labeler DUNS
- 153608369
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2025-09-15
- Public Version Status
- Update
- Public Device Record Key
- 9fc156a8-0fd8-4f75-84de-ea7a05873a45
- Distribution End Date
- 2025-09-12
Device Description
SYRINGE CAP DUAL CAPACITY BLUE
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 |
|---|---|---|---|---|
| 61614 | Breath specimen container IVD | A container (e.g., bag, tube, collection card) intended to contain a specimen of air exhaled from a patient for subsequent in vitro determination of chemical and/or biological markers (e.g., volatile organic compounds) in the specimen to aid metabolic profiling or the diagnosis of disorders [e.g., lipid peroxidation levels, gastrointestinal H. pylori infection, coronavirus disease (COVID-19) infection]. It typically consists of carbon dioxide (CO2) absorbing material which may be encased within the container, a port/mouthpiece or an access device (e.g., tubing) to facilitate specimen collection, and/or an adaptor for connection to an analyser. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10842472103011 | GS1 | 100 | Not in Commercial Distribution | 2025-09-12 | |
| Primary | 00842472103014 | GS1 |
Customer Contacts
- Phone
- 800-967-6400
- [email protected]