FDA UDI
In Commercial Distribution
🇺🇸 United States
SPACE
DI: 04046963418373
·
Model: 8713152
·
B. BRAUN MEDICAL INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SPACE
- Primary DI
- 04046963418373
- Version / Model
- 8713152
- Catalog Number
- 8713152
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-21
- Public Version
- 6
- Public Version Date
- 2026-04-02
- Public Version Status
- Update
- Public Device Record Key
- 477cfef7-4c3c-4e8b-a824-1c055ace740e
Device Description
SpaceStation MRI
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRN | Pump, infusion | General Hospital | 880.5725 | 2 |
| MRZ | ACCESSORIES, PUMP, INFUSION | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36179 | Multiple infusion pump management station | An electrically-powered unit designed for the bedside organization, management, operating control of infusion parameters, pump performance monitoring, and electrical supply of multiple infusion and/or syringe pumps that are being used simultaneously or sequentially. It typically consists of a tower rack with slots for the pumps, electrical sockets, infusion controls (e.g., automated relay changeovers between pumps), and alarms; some types have a user interface software/display, magnetic shielding properties for use during resonance imaging (MRI) procedures, and may be capable of detecting magnetic flux density to monitor pump performance during MRI. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046963418373 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care
- Type
- Special Storage Condition, Specify
- Special Conditions
- This way up
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal