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
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