FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327154920
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJAAHY26C
Catalog number
DYNJAAHY26C
Device description
RESUS HYPERINF SYSTEM 1/4L-LF
Published
2022-05-08
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327154920PackageGS150In Commercial Distribution
10195327154929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532715492040195327154920
1019532715492910195327154929

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
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
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612649217604ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217628PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217642ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217666ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217680PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217703PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217727ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
06923980116179N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116186N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116193N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116209N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
0503026717028922MM SMOOTHBORE BILEVEL BREATHING SYSTEM FOR NKV-330 WITH MONIT. LINEIntersurgical IncorporatedCAI2026-08-18
14896138016692inspired™VINCENT MEDICAL MANUFACTURING CO., LIMITEDCAI2026-08-05
04719874956547Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
04719874956554Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
00848530108809Ventilator accessorySunset Healthcare Solutions, Inc.CAI2026-04-27
10889483584705Vital Signs™AIRLIFECAI2025-03-06
10889483591666Vital Signs™AIRLIFECAI2025-02-18
10889483591925Vital Signs™AIRLIFECAI2025-02-18
10889483591987Vital Signs™AIRLIFECAI2025-02-18
10889483592113Vital Signs™AIRLIFECAI2025-02-18
10889483592496Vital Signs™AIRLIFECAI2025-02-18
10889483592656Vital Signs™AIRLIFECAI2025-02-18
10889483593448Vital Signs™AIRLIFECAI2025-02-18
10889483593561Vital Signs™AIRLIFECAI2025-02-18
10889483593660Vital Signs™AIRLIFECAI2025-02-18
10889483593752Vital Signs™AIRLIFECAI2025-02-18
10889483585627Vital Signs™AIRLIFECAI2025-02-17
10889483585801Vital Signs™AIRLIFECAI2025-02-17
10889483584699Vital Signs™AIRLIFECAI2025-02-11