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
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
20889483228828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948322882820889483228828

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10889483054321AirLife™048004802025-12-18
10889483054338AirLife™079507952025-12-19
10889483229422AirLife™048504852025-12-19
10889483564288BALLARD™22103-522103-52025-11-20
10889483564394BALLARD™22113-522113-52025-11-21
10889483564608BALLARD™227101322710132025-11-24
10889483564646BALLARD™22712183227121832025-11-24
10889483564806BALLARD™2271603-52271603-52025-11-21
10889483564813BALLARD™22716036-522716036-52025-11-21
10889483564905BALLARD™227166-5227166-52025-11-21
10889483564936BALLARD™2276-52276-52025-11-21
10889483567005BALLARD™2271652271652025-11-24
10889483623411BALLARD™22056-522056-52025-11-20
10889483623541BALLARD™2271516-52271516-52025-11-21
10889483562611BALLARD™227-5227-52025-11-21
10889483564370BALLARD™22108-522108-52025-11-21
10889483564424BALLARD™2255-52255-52025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109875Ventilator accessorySunset Healthcare Solutions, Inc.BZO2026-10-27
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04055146499467Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499474Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499481Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499498Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499634Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001393Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001409Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146040935Breathing set, unheatedWILAmed GmbHBZO2026-10-19
04048675826088VentStar Coax GSL 180Drägerwerk AG & Co. KGaABZO2026-10-15
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