AccessGUDID - DEVICE: Medline (10193489001655)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: HCS53006K
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HCS53006K
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10193489001655
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: DBD-KEY, CART, OXYGEN

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:	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?
35086	Gas cylinder trolley	A dedicated cart designed to hold and secure one or more medical gas cylinders of compressed gas; but may be used for other types of gases, both during transport and static placement. The usual gases are [e.g., oxygen (O2), air, nitrous oxide (N2O) or helium (He)]. This trolley (cart) is used to prevent the cylinder(s) from falling both during transport and whilst the gas is being used. It is typically constructed of a metal framework [coated iron (Fe) or aluminium (Al)] and designed for standing upright on the floor when not in transport. It is configured to hold a certain size of gas cylinder(s) and will include a handle, a cylinder(s) securing device, and a pair of wheels.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 74ad5cbc-361b-42af-a852-705cf5777a64
Public Version Date: July 21, 2021
Public Version Number: 1
DI Record Publish Date: July 13, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20193489001652	250	10193489001655		In Commercial Distribution	CASE

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-5463
Email: service@medline.com

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