AccessGUDID - DEVICE: BD Sputum Collection System (30382902900208)

GUDID

Device Identifier (DI) Information

Brand Name: BD Sputum Collection System
Version or Model: 290020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 290020
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902900208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 72
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Sputum Collection System, Case of 72 units

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?
58169	Oral/respiratory tract specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTW	SYSTEM, TRANSPORT, AEROBIC

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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 525a029f-68ae-48e8-9711-1410bb216259
Public Version Date: November 27, 2024
Public Version Number: 1
DI Record Publish Date: November 19, 2024