FDA.reportPublic FDA data

McKesson

Primary DI
40612479208412
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-116E
Device description
Face Tent ADULT 8’ (2.4 m) EXPANDABLE AEROSOL TUBING | SINGLE PATIENT USE
Published
2020-07-21
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

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479208412PackageGS150In Commercial Distribution
20612479208401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247920841240612479208412
2061247920840120612479208401

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration face tentA flexible, tent-like, enclosure designed to rest against the chin of the patient while remaining away from the face to provide a semi-enclosed environment of enriched oxygen (O2) to increase the patient's O2 uptake. It is connected to a high-flow O2 source and/or humidifier through wide bore tubing. It typically consists of a small rigid plastic device that is contoured around the chin and attached with head straps for stabilization. It is typically used for patients that are adverse to oxygen delivery devices such as a nasal cannula or face mask, usually due to facial surgery or trauma. This is not an O2 face mask. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874950675Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874950972Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951153Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951160Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951177Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874951184Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955793Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955809Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874955816Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956264Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956271Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956288Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956295Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956301Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
04719874956318Create BiotechCREATE BIOTECH CO., LTD.BYG2026-07-21
00607411919039Salter Labs® High Concentration partial rebreatherSALTER LABSBYG2026-06-10
00607411919336Salter Labs® Percent-O2-Lock® MaskSALTER LABSBYG2026-06-10
00607411919008Salter Labs® Adult Comfort Face TentSALTER LABSBYG2026-06-09
00607411919053Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
00607411919060Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29