AccessGUDID - DEVICE: Vermed (00009336006571)

GUDID

Device Identifier (DI) Information

Brand Name: Vermed
Version or Model: SHRP18 GAL CHEMO W/FLAT/MONO LID
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32028118
Company Name: GRAPHIC CONTROLS ACQUISITION CORP

Primary DI Number: 00009336006571
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002111896 *Terms of Use

Device Description: SHRP18 GAL CHEMO W/FLAT/MONO LID

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
Prescription Use (Rx):	No
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?
36021	Cytotoxic waste container	A container made of metal, hard plastic and/or cardboard designed for the safe deposit, collection and storage of cytotoxic materials (e.g., chemotherapy/antineoplastic drugs). It is typically used with a liner or a sealed leak proof bag, and has a lid for that allows temporary and final closure options; the lid typically includes a seal to prevent leakage. It is identified with a cytotoxic biohazard symbol on its labelling and sent to an appropriate waste treatment plant for disposal when filled to the recommended level.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMK	Container, Sharps

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071517	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b8d4b8a1-6571-4a76-9590-6873f96ffa87
Public Version Date: August 18, 2023
Public Version Number: 4
DI Record Publish Date: January 24, 2017