AccessGUDID - DEVICE: BodyGuard® Microset with Needleless Y-Site (B101A120003XYVA0)

GUDID

Device Identifier (DI) Information

Brand Name: BodyGuard® Microset with Needleless Y-Site
Version or Model: A120-003XYVA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CME AMERICA LLC

Primary DI Number: B101A120003XYVA0
Issuing Agency: HIBCC
Commercial Distribution End Date: November 04, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 002125419 *Terms of Use

Device Description: 150 in. (380 cm) For Use with the BodyGuard® Infusion Pump

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?
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042696	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 40843eae-2b94-4187-b704-6ca4c7d92c18
Public Version Date: July 09, 2020
Public Version Number: 4
DI Record Publish Date: August 30, 2016