FDA.reportPublic FDA data

Sunmed

Primary DI
00847946046163
Brand
Sunmed
Company
Zoll Medical Corporation
Model
912-0010-20
Device description
MASK, FLEX CPAP, #5, LARGE ADULT, CASE OF 20
Published
2021-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00847946046163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946046163008479460461638479460461630847946046163

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia mask strap, single-useA non-sterile, non-latex strap/head harness intended to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and affixed to the mask. It is typically used for anaesthesia of long duration. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal0
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055363428
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198843002876bellavista302.396.000-402026-07-06
00198843001145bellavista301.328.020-402026-06-24
00198843001152bellavista301.470.020-402026-06-24
00198843003347Infant Flow™777000XS-402026-06-24
00198843003361Infant Flow™777000S-402026-06-24
00198843003385Infant Flow™777000M-402026-06-24
00198843003408Infant Flow™777000L-402026-06-24
00198843003422Infant Flow™777000XL-402026-06-24
00198843003545Infant Flow™777040XS-402026-06-24
00198843003552Infant Flow™777040S-402026-06-24
00198843003569Infant Flow™777040SM-402026-06-24
00198843003576Infant Flow™777040M-402026-06-24
00198843003583Infant Flow™777040L-402026-06-24
00198843003590Infant Flow™777040XL-402026-06-24
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODE8900-004040-012026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODE8900-004041-012026-05-29
00847946021986HWD Electrode Set9610-000181-012016-10-20
10847946021327Cuffs9355-16402016-09-16
10847946021334Cuffs9355-16412016-09-16
10847946021341Cuffs9355-16422016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704664983HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704664990HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665003HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665027HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665034HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665164HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665171HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665195HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
14026704665201HUDSON RCITELEFLEX INCORPORATEDBSJ2026-06-24
05030267156177ECONOMY, ANAESTHETIC FACE MASK, SIZE 0, NEONATE, NO HOOK RING, 15MIntersurgical IncorporatedBSJ2026-06-10
05030267156184ECONOMY, ANAESTHETIC FACE MASK, SIZE 1, INFANT, NO HOOK RING, 15MIntersurgical IncorporatedBSJ2026-06-10
05030267156191ECONOMY, ANAESTHETIC FACE MASK, SIZE 2, PAEDIATRIC, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156207ECONOMY, ANAESTHETIC FACE MASK, SIZE 3, SMALL ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156214ECONOMY, ANAESTHETIC FACE MASK, SIZE 4, MEDIUM ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156221ECONOMY, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
05030267156238ECONOMY, ANAESTHETIC FACE MASK, SIZE 6, EXTRA LARGE ADULT, NO HOOK RING, 22FIntersurgical IncorporatedBSJ2026-06-10
10192253071405CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-04-06
10192253071412CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071429CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071436CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071443CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071450CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10192253071467CARDINAL HEALTHCardinal Health 200, LLCBSJ2026-03-23
10197344137435MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-03-05
10197344131662MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10197344131693MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10197344131723MEDLINEMEDLINE INDUSTRIES, INC.BSJ2025-01-31
10612479274218McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274232McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31
10612479274256McKessonMCKESSON MEDICAL-SURGICAL INC.BSJ2025-01-31