AccessGUDID - DEVICE: 15 mm Adaptor (EBES3110040)

GUDID

Device Identifier (DI) Information

Brand Name: 15 mm Adaptor
Version or Model: 311004
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 311004
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBES3110040
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size 10 x 15 mm

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:	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?
61346	Straight/elbow breathing circuit connector, single-use	A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTO	Tube, Tracheostomy (W/Wo Connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K802916	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
Device Size Text, specify: Size 10 x 15 mm

Device Record Status

Public Device Record Key: 1c46ed6c-2592-4f6e-9277-11931aa7942b
Public Version Date: November 28, 2022
Public Version Number: 8
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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