FDA.reportPublic FDA data

SunMed

Primary DI
20889483228804
Brand
SunMed
Company
SUNMED, LLC
Model
4-1054-23-10
Device description
Adult Mask Harness
Published
2020-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483228804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948322880420889483228804

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia mask strap, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
069009268
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483222065VixOne™020502052025-12-19
10889483224533VixOne™022302232025-12-19
10889483230046VixOne™032503252025-12-19
10889483231234VixOne™023302332025-12-19
10889483495742Pedi-Neb™3655PN-6123655PN-6122025-12-19
10889483002742Mask Harness4-1054-222026-03-19
30889483631472AirLifeFC0010FC00102026-02-27
20889483033309SunMed09-0203-0609-0203-062026-02-18
20889483033316SunMed09-0203-1009-0203-102026-02-18
20889483033323SunMed09-0203-1409-0203-142026-02-18
20889483230005VixOne™031103112026-02-11
20889483300135Respan®R-8270R-82702026-02-11
30889483562615BALLARD™227-5227-52025-11-21
30889483563391BALLARD™12601126012025-11-19
30889483563681BALLARD™196812718681272025-11-19
30889483563711BALLARD™197812719781272025-11-19
30889483567030BALLARD™821582152025-11-19
30889483623316BALLARD™21603-4J21603-4J2025-11-21
30889483623323BALLARD™216036-4J216036-4J2025-11-21
30889483623347BALLARD™2160-4J2160-4J2025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923980112546MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-26
16923980111843MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-26
06923980112522MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-25
06923980112539MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-25
06944904007465MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-25
06944904007472MindrayGaleMed Xiamen Co., Ltd.BZO2026-05-25
20197344011343HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
20197344011350HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
20197344011374HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
44710810100329N/AGALEMED CORPORATIONBZO2026-03-05
44710810107311N/AGALEMED CORPORATIONBZO2026-03-04
04719894389189VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
04719894389196VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
04719894389202VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-28
09420012479112F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479136F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479150F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479174F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
46923980106406N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
46923980106413N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
46923980106420N/AGaleMed Xiamen Co., Ltd.BZO2026-01-22
14719894389162VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-20
04719894389172VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2026-01-20
20889483225650AirLife™SUNMED, LLCBZO2025-12-19
44710810088405N/AGALEMED CORPORATIONBZO2025-12-18
14719894386314VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386321VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386338VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386345VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01
14719894386352VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.BZO2025-08-01