Home GUDID 20889483228828 SunMed
Primary DI 20889483228828
Brand SunMed
Company SUNMED, LLC
Model 4-1054-21-10
Device description Infant Mask Harness
Published 2020-02-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name BZO Set, Tubing And Support, Ventilator (W Harness)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20889483228828 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20889483228828 20889483228828
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 069009268 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05404013001507 Classic Plastiflex Group BZO 2026-09-21 05404013001521 Classic Plastiflex Group BZO 2026-09-21 00848530109813 Aerosol Sunset Healthcare Solutions, Inc. BZO 2026-09-09 14026704929204 GIBECK TELEFLEX INCORPORATED BZO 2026-08-01 04719874950637 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874950644 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874950651 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874951139 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874951146 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874957483 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874957919 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874959128 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874959487 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874959494 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874959500 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874959517 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 04719874959524 Create Biotech CREATE BIOTECH CO., LTD. BZO 2026-07-21 00848530108854 Breathing Circuit Sunset Healthcare Solutions, Inc. BZO 2026-05-12 00848530108861 Breathing Circuit Sunset Healthcare Solutions, Inc. BZO 2026-05-12 00848530108878 Breathing Circuit Sunset Healthcare Solutions, Inc. BZO 2026-05-12 09420012402691 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED BZO 2026-03-26 09420012433756 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED BZO 2026-03-26 10197344011346 HUDSON RCI MEDLINE INDUSTRIES, INC. BZO 2026-03-13 10197344011353 HUDSON RCI MEDLINE INDUSTRIES, INC. BZO 2026-03-13 10197344011377 HUDSON RCI MEDLINE INDUSTRIES, INC. BZO 2026-03-13 09420012479105 F&P OptiPAP Junior FISHER & PAYKEL HEALTHCARE LIMITED BZO 2026-01-23 09420012479129 F&P OptiPAP Junior FISHER & PAYKEL HEALTHCARE LIMITED BZO 2026-01-23 09420012479143 F&P OptiPAP Junior FISHER & PAYKEL HEALTHCARE LIMITED BZO 2026-01-23 09420012479167 F&P OptiPAP Junior FISHER & PAYKEL HEALTHCARE LIMITED BZO 2026-01-23 10889483225653 AirLife™ SUNMED, LLC BZO 2025-12-19