AccessGUDID - DEVICE: SAFELINE® (04046964187612)

GUDID

Device Identifier (DI) Information

Brand Name: SAFELINE®
Version or Model: NF9280
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NF9280
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964187612
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2020
Device Count: 100
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: SafeLine® Multidose Vi al Adaptor

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?
58510	Vial transfer spike	A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial’s sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the vial’s contents (e.g., liquid medication) by providing a sterile pathway between the vial and a recipient receptacle/device for subsequent delivery to a patient. It typically consists of polyvinyl chloride (PVC) screw cap with an internal spike and an external connector. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aaab1f2e-f1d5-4e3a-985a-47c34e92786d
Public Version Date: July 07, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016