FDA.reportPublic FDA data

AirLife

Primary DI
50885403184299
Brand
AirLife
Company
Carefusion Corporation
Model
RES411956B
Catalog number
RES411956B
Device description
Airlife™ Face Tent Mask, 7' O2 Tube, O2 Stem with Plug Face Tent Mask, 7' O2 Tube, O2 Stem with Plug 22mm OD x 18mm ID
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGLOxygen administration kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGLOxygen Administration KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403184299PackageGS150Not in Commercial Distribution
10885403184291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540318429950885403184299
1088540318429110885403184291

GMDN Terms#

Term, Definition table
TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
830432451
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403296864enFlow980304VS30980304VS302016-09-21
10846446001693Vela11571115712017-06-23
10885403272424AirLife6098ADPG6098ADPG2016-09-01
10885403272431AirLife6098DPG6098DPG2016-09-01
10885403001024AirLife5007P5007P2016-09-01
10885403006425AirLife0020020020022016-09-01
10885403006524AirLife0024300024302016-09-01
10885403006531AirLife0024310024312016-09-01
10885403006548AirLife0024330024332016-09-01
10885403006555AirLife0024340024342016-09-01
10885403006562AirLife0024350024352016-09-01
10885403006579AirLife0024380024382016-09-21
10885403006586AirLife0024430024432016-09-01
10885403006593AirLife0024440024442016-09-01
10885403010958AirLife0024460024462016-09-01
10885403010996AirLife0025010025012016-09-01
10885403011726AirLife0016180016182016-09-01
10885403026980AirLife6200-5046200-5042016-09-01
10885403027079AirLife6934-5046934-5042016-09-01
10885403039072AirLife0021730021732016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530104443Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530104450Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530105402Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108915Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108922Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-22
00848530108908Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-20
00848530108595Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-13
00848530108601Repair LabelSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-13
00848530108526Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108533Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108625Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108762Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-04-07
00848530108649Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108663Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108687Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108646Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108660Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
10848530108684Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-17
00848530108571Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-09
00848530108588Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-03-09
00848530108434Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-02-18
00848530108311Oxygen KitSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-02-11
00848530108304Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-26
00848530108229REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108243REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108250REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108226REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
00848530108236REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108240REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19
10848530108257REPAIR PARTSUNSET HEALTHCARE SOLUTIONS, INC.OGL2026-01-19