FDA.reportPublic FDA data

O-Two

Primary DI
07540195010147
Brand
O-Two
Company
O-Two Medical Technologies Inc
Model
02FM5101
Catalog number
02FM5101-CS
Device description
O-Two Resuscitation and Anesthesia Facemasks are intended to be used with automatic ventilator/manual resuscitator or anesthesia machine to provide a mask to face seal which covers both mouth and nose during resuscitation or anesthesia. The clear Silicone facemasks are ideal for anesthesia as they withstand repeated autoclaving. The Infant Silicone Face Mask 02FM5101 fits infant patients.
Published
2019-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSJMask, Gas, Anesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540195010144PackageGS112In Commercial Distribution
07540195010147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754019501014417540195010144
07540195010147075401950101477540195010147

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, reusableA 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 reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-387-3405cs@otwo.com

Regulatory Flags#

DUNS number
206449154
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540195015029O-Two 17MP13292023-11-07
07540195015036O-Two 17MP11302023-11-07
07540195020252O Two 01DV2000-FER2024-04-29
07540195020269O Two 01DV2000-FER2024-04-29
17540195040073Pro NoxCMI-0100-PNX 2023-11-13
07540195015012O-Two 08GL1042U2023-11-07
07540195050051O-Two 01FCO115D2023-11-07
07540195050075O-Two 01FCO125D2023-11-07
07540195035157O-Two 01CV02202023-06-22
17540195035154O-Two 01CV02202023-06-22
07540195060111O-TWO 01RO01O10-B2023-06-06
07540195060241O-TWO 01RO01O23-B2023-06-06
07540195086616O-TWO 01RN09N10-B2023-06-06
07540195005174O-Two01CV801501CV8015-CS2019-05-31
07540195005181O-Two01CV801601CV8016-CS2019-05-31
07540195005211O-Two01CV801901CV8019-CS2019-05-31
07540195005334O-Two01CV803001CV8030-CS2019-05-31
07540195005129O-Two01CV801001CV8010-CS2019-05-31
07540195071308O-Two02RT101002RT1010-CS2019-10-31
07540195071322O-Two02RT101202RT1012-CS2019-10-31

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