AccessGUDID - DEVICE: B.BRAUN (04046964187759)

GUDID

Device Identifier (DI) Information

Brand Name: B.BRAUN
Version or Model: S9900-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S9900-10
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964187759
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Evacuated IV Container, Glass, 1000 mL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
For Single-Use:	Yes
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?
15808	Evacuated intravenous fluid container	A receptacle with a relative vacuum in its interior designed to be filled with intravenous (IV) fluids. It is typically an empty, pre-sealed container (e.g., glass bottles) with appropriate shape and size (usually in a range from 250 to 2000 ml) for IV solutions. It is mainly intended to facilitate filling by intravenous fluid compounders; it is typically used in clinical pharmacies and/or other healthcare departments and facilities. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPE	CONTAINER, I.V.

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7dcbce8c-ba50-49e0-a6ef-5168767fc118
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016

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: 04046964187742 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: No
Expiration Date: Yes
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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