AccessGUDID - DEVICE: SAFELINE® (04046964187582)

GUDID

Device Identifier (DI) Information

Brand Name: SAFELINE®
Version or Model: NF9210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NF9210
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964187582
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: BLUNT CANNULA

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):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Medicine preparation needle/cannula, sterile	A sterile slender metallic or plastic tube with a blunt distal end intended to be attached to a syringe in order to aspirate pharmaceutical fluids from vials or ampules during the preparation of some medications performed by healthcare professionals (e.g., pharmacists, physicians, nurses). This device is not intended for skin injections or tissue manipulation. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
FPA	Set, administration, intravascular

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51649c86-952f-4752-a680-ef1389bc40e6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016