FDA.report

CLEARLITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, 15M

Primary DI
05030267153275
Brand
CLEARLITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, 15M
Company
INTERSURGICAL INCORPORATED
Model
7291000
Device description
CLEARLITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, 15M
Published
2021-10-15
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
BSJMask, Gas, Anesthetic

Product Code Classifications

CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267153275PackageGS130In Commercial Distribution
05030267152247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267153275050302671532755030267153275
05030267152247050302671522475030267152247

GMDN Terms

TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. 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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