AccessGUDID - DEVICE: ACE (00614950017072)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 0039940
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0039940
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950017072
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: CATHETER ONLY 14G 2" NS TEFLON PLAS HUB 10/PKG L/F

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:	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?
18067	Intravenous line recessed-needle connector	A sterile device designed to allow access to either the Y-site of an intravenous (IV) line or an injection adaptor on the infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard septum and a Luer fitting located at the opposite end allows the connection of a syringe or infusion set. A manual or automated mechanism moves the housing to protect the operator from the needle once the infusion is finished. The device is intended to eliminate an exposed needle after administration of medications. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCB	NEEDLE, CATHETER

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: No special storage conditions required

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Inch

Device Record Status

Public Device Record Key: b05f19d3-8bd5-48bf-9343-5eeb8d2435c3
Public Version Date: October 18, 2019
Public Version Number: 1
DI Record Publish Date: October 10, 2019