AccessGUDID - DEVICE: SPACE (04046963418373)

GUDID

Device Identifier (DI) Information

Brand Name: SPACE
Version or Model: 8713152
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8713152
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046963418373
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: SpaceStation MRI

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36179	Infusion pump management unit, mobile	A mains electricity (AC-powered) mobile unit designed for the bedside organization, management, monitoring and electrical supply of many infusion pumps that are being used simultaneously to supply one patient. This device will be found in the intensive care unit (ICU) and helps achieve a high degree of organization of, e.g., the different infusion pumps, syringe pumps, the infusion sets and lines and the medication being infused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, infusion
MRZ	ACCESSORIES, PUMP, INFUSION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify:
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep dry
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Special Storage Condition, Specify: Fragile, handle with care
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 477cfef7-4c3c-4e8b-a824-1c055ace740e
Public Version Date: August 17, 2023
Public Version Number: 4
DI Record Publish Date: August 21, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)227-2862
Email: BBMUS_Service.EmailOrders@bbraun.com

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