AccessGUDID - DEVICE: N/A (00857863007888)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: MN9676
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medi/Nuclear Corporation, Inc.

Primary DI Number: 00857863007888
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079628327 *Terms of Use

Device Description: Face Mask Harness, Soft Rubber, Adult size

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:	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?
60882	Anaesthesia mask strap, single-use	A non-sterile, non-latex strap/head harness intended to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and affixed to the mask. It is typically used for anaesthesia of long duration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTK	Strap, Head, Gas Mask

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: store at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b9aba296-3377-479f-b6bb-1eca3b669874
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 09, 2017

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

Customer Contact

[?]

Phone: 800-321-5981
Email: cs@medinuclear.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES