AccessGUDID - DEVICE: Resp-O2 Mucus Specimen Trap, Leak Proof Transport Cap, 40 cc, Sterile (00840117310377)

GUDID

Device Identifier (DI) Information

Brand Name: Resp-O2 Mucus Specimen Trap, Leak Proof Transport Cap, 40 cc, Sterile
Version or Model: 32270
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00840117310377
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: No description.

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):	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?
62853	Oropharyngeal secretion specimen suction kit	A collection of non-powered devices intended exclusively for professional use to obtain by suction a mucus/sputum specimen from the oropharynx of a neonate for microbiological examination; it might in addition be used to clear mucus from the oropharynx to assist respiration. It consists of a catheter/tube intended to be inserted orally, a piece of suction tubing intended to be attached to an appropriate pump (not included), an empty specimen collection container, and appropriate adapters/lids. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYZ	Trap, Sterile Specimen

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: 03613e79-01c1-40cb-8698-c1870b557619
Public Version Date: January 20, 2025
Public Version Number: 5
DI Record Publish Date: April 22, 2021