AccessGUDID - DEVICE: Administration Set (00301697200064)

GUDID

Device Identifier (DI) Information

Brand Name: Administration Set
Version or Model: 720006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 720006
Company Name: NOVO NORDISK INC.

Primary DI Number: 00301697200064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012177531 *Terms of Use

Device Description: Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, and 2 bandages.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
45158	Percutaneous medicine administration kit, non-medicated, single-use	A collection of sterile devices intended to be used to administer various types of medication (non-dedicated) by injection. It will typically contain a syringe, a needle, extension tubing, adaptors, and antiseptic applicator, but not the medication. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LRS	I.V. Start Kit

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not store at extreme temperatures and humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54bcba21-9d0c-4be2-b00a-44d828fd3e1c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 13, 2017