AccessGUDID - DEVICE: MediChoice (10885632113277)

GUDID

Device Identifier (DI) Information

Brand Name: MediChoice
Version or Model: IVS1005
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632113277
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Kit Iv Start Chloraprep Frepp Tegaderm 2 3/8X2 3/4In 2X2In Gauze 3/4X18In Rolled Tourniquet 3/4X18In Transpore Tape Label Latex-Free Sterile MediChoice

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:	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?
33963	Peripheral intravenous catheterization support kit	A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). 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 [?]
K923361	000

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
Special Storage Condition, Specify:
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Special Storage Condition, Specify: Avoid freezing and excessive heat

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 172f4316-6d89-4330-b7f8-9877e270e0ac
Public Version Date: October 16, 2023
Public Version Number: 3
DI Record Publish Date: October 12, 2020