FDA.report

Medline Industries, Inc.

Primary DI
40889942487807
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJAA10555
Catalog number
DYNJAA10555
Device description
ANESTHESIA CIRCUIT-LF
Published
2023-07-29
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

Related Records

Contact Domains

Product Codes

CodeName
OFQAnesthesia kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40889942487807PackageGS120In Commercial Distribution
10889942487806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4088994248780740889942487807
1088994248780610889942487806

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10198956472716CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-05-25
10198956482227CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-05-25
50198956315998CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956318999CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956323108CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956343366CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956379815CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956382235CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956382396CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956409666CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956425321CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-23
50198956220704CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-19
50198956316797CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-19
50198956331844CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-19
50198956258530CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956377828CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956385007CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956400977CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-16
50198956285451CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-10
50198956369854CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-10
50198956390650CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-10
50198956329582CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956343113CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956348941CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956359787CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956395365CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-09
50198956350104CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06
50198956364866CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06
50198956369380CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06
50198956390933CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-03-06