FDA.report

Sunset Ruby Style Chin Strap - Small

Primary DI
10848530040571
Brand
Sunset Ruby Style Chin Strap - Small
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
CS007S
Catalog number
CS007S
Device description
Sunset Ruby Style Chin Strap - Small
Published
2018-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BTKStrap, Head, Gas Mask

Product Code Classifications

CodeDeviceSpecialtyClass
BTKStrap, Head, Gas MaskAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10848530040571PackageGS1100In Commercial Distribution
00848530040574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853004057110848530040571
00848530040574008485300405748485300405740848530040574

GMDN Terms

TermDefinition
Anaesthesia mask strap, reusableA band of material designed to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and often affixed to a special stabilizing device (e.g., with hooks) located on the gas connection port of the mask. It is typically used for anaesthesia of long duration. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags

DUNS number
141668116
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DIBrandCompanyProduct codePublished
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16946430423310CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
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30889483606869AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606876AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606890AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
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