FDA.report

INTERSURGICAL ECOLITE ADULT TRACHEOSTOMY MASK

Primary DI
05030267100569
Brand
INTERSURGICAL ECOLITE ADULT TRACHEOSTOMY MASK
Company
INTERSURGICAL INCORPORATED
Model
1200050
Device description
INTERSURGICAL ECOLITE ADULT TRACHEOSTOMY MASK
Published
2021-10-11
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

Related Records

Contact Domains

Product Codes

CodeName
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267100569PackageGS130In Commercial Distribution
05030267100552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267100569050302671005695030267100569
05030267100552050302671005525030267100552

GMDN Terms

TermDefinition
Tracheostomy mask, aerosolA device designed to deliver air, oxygen, or a mixture of the two gases with aerosolized water particles to a patient who has a tracheostomy airway. It is typically connected to an oxygen source and nebulizer with wide bore tubing and is constructed of plastic. The device can be used over a tracheostomy tube or a stoma and is secured with a strap. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F122200051948502025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F122300051948502025-09-25
05030267124121ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F122400051948502025-09-25
05030267124077ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F122500051948502025-09-25
05030267124138ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22122600051948502025-09-25
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