Device
22mm O.D. x 28mm I.D. x 22mm I.D. x 4.5mmO.D. Jet T-PIECE ADAPTOR w/o Manometer MOUTHPIECE ADAPTER
Manufacturer
D R BURTON HEALTHCARE, LLC
Model: 1 Catalog: 557 DI: 00851232007677 Status: Update MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2019-08-23 Current Version: 2026-05-21
Description
22mm O.D. x 28mm I.D. x 22mm I.D. x 4.5mmO.D. Jet T-PIECE ADAPTOR w/o Manometer MOUTHPIECE ADAPTER
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 6
Record Key: e1b5f1bb-92b4-44f1-8a7a-97dd07279edb
Distribution Status: In Commercial Distribution
DUNS Number: 080384219
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Device ID: 00851232007677
Item #1 - Device ID Type: Primary
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Pkg Type: CASE
Item #2 - Device ID: 20851232007671
Item #2 - Pkg Status: In Commercial Distribution
Item #2 - Pkg Quantity: 10
Item #2 - Device ID Type: Package
Item #2 - Contains DINumber: 00851232007677
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 44545
Name: Breathing mouthpiece, single-use
Definition:
A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.
FDA Product Codes
BYP
Mouthpiece, Breathing