FDA.reportPublic FDA data

McKesson

Primary DI
40612479274264
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
712-GR
Device description
Anesthesia mask, Adult, Small
Published
2025-01-31
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
BSJMask, Gas, Anesthetic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953107000ANESTHESIA/RESPIRATORY FACE MASKMedical Marketing Concepts1995-08-15BSJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479274264PackageGS120In Commercial Distribution
10612479274256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247927426440612479274264
1061247927425610612479274256

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06946430427557CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427571CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427595CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427618CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
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14026704665249HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665256HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665263HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665270HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665041RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665065RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665072RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665089RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665096RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
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10192253072075CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072082CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
10192253072105CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-07-29
04719874951085Create BiotechCREATE BIOTECH CO., LTD.BSJ2026-07-21