AccessGUDID - DEVICE: Res-Q-Vac (00659443002142)

GUDID

Device Identifier (DI) Information

Brand Name: Res-Q-Vac
Version or Model: P1N1S114S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: P1N1S114S
Company Name: REPRO MED SYSTEMS, INC.

Primary DI Number: 00659443002142
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 048403299 *Terms of Use

Device Description: PUMP NSC SOFT 14FR 35/14 ST

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:	Yes
Prescription Use (Rx):	No
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?
47368	Emergency airway clearance suction system, manual	A portable assembly of devices, which includes an orally-introduced handpiece/tip, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). In addition to the handpiece/tip, it includes a manually-powered (hand or foot-operated) suction pump, a collection container, and typically microbial/hydrophobic filters. The system is not intended for surgical use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSY	CATHETERS, SUCTION, TRACHEOBRONCHIAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

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: cf664a93-f171-44a3-894a-bd8d159ad662
Public Version Date: October 03, 2025
Public Version Number: 6
DI Record Publish Date: August 19, 2016