AccessGUDID - DEVICE: Endure (B531OA1220)

GUDID

Device Identifier (DI) Information

Brand Name: Endure
Version or Model: OA1221217
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OA122
Company Name: ENDURE INDUSTRIES

Primary DI Number: B531OA1220
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066087031 *Terms of Use

Device Description: Oropharyngeal Airway, Size 120 mm, Non-Sterile

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:	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?
42424	Oropharyngeal airway, single-use	A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAE	Airway, Oropharyngeal, Anesthesiology

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
Storage Environment Temperature: between 0 and 49 Degrees Celsius
Handling Environment Temperature: between 0 and 49 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 120 Millimeter

Device Record Status

Public Device Record Key: 983fc2c8-7bc1-43eb-8d5c-90a6ab936881
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: February 20, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B531OA1222	10	B531OA1221		In Commercial Distribution	Carton
B531OA1221	15	B531OA1220		In Commercial Distribution	Box

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

Customer Contact

[?]

Phone: 6072994971
Email: support@endureind.com

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