AccessGUDID - DEVICE: HMS Lubricant Kit (EBES820950)

GUDID

Device Identifier (DI) Information

Brand Name: HMS Lubricant Kit
Version or Model: 82095
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82095
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBES820950
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
57897	Tracheostomy tube lubricant	A non-sterile substance made of oil (e.g., paraffin) designed to be applied by healthcare staff or a patient to the outer surface of a tracheostomy tube inner cannula to facilitate its easy sliding into the outer cannula (e.g., after cleaning). The lubrication is intended to reduce frictional forces so that less physical force is required for inner cannula insertion and to help prolong the life of the tube's cannulae. It is typically available in a squeeze or dropper bottle. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTR	Tube, Tracheal (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K912290	000

Device Exempt from Premarket Submission: No 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: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 157356de-2e3a-457e-ba3b-a23514248009
Public Version Date: August 30, 2022
Public Version Number: 4
DI Record Publish Date: September 20, 2015

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

Customer Contact

[?]

Phone: 1-800-433-2674
Email: info@bosmed.com

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