AccessGUDID - DEVICE: MD Resource (00859898006454)

GUDID

Device Identifier (DI) Information

Brand Name: MD Resource
Version or Model: RM2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RM2000
Company Name: MEDICAL DEVICE RESOURCE CORPORATION

Primary DI Number: 00859898006454
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 126830020 *Terms of Use

Device Description: RM2000 Aspirator

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?
10217	Surgical suction system	An assembly of devices designed to evacuate large volumes of gas, liquid, tissue and/or other debris from a surgical site by means of suction during surgical procedures. It generally consists of a mains electricity (AC-powered) suction pump, a regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The vacuum capability should be at least 400 mm Hg; free flow rates may be as high as 35 litter/min. The system is mainly used when suction from a central vacuum system is not available or appropriate.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K850704	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: cb5a686f-45d2-4f51-a9f3-3cea17358d38
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 13, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 510-732-9950
Email: sales@mdresource.com

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