FDA.reportPublic FDA data

Medline

Primary DI
20888277700519
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
CPRM4426M
Catalog number
CPRM4426M
Device description
RESUSC, SMALL ADLT,MASK,TUB RES, MANO
Published
2021-09-22
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
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277700519PackageGS16In Commercial Distribution
10888277700512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827770051920888277700519
1088827770051210888277700512

GMDN Terms#

Term, Definition table
TermDefinition
Resuscitator face mask, single-useA non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
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
true
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012073535butterflyBVMCompact Medical Inc.BTM2026-03-13
00860012073559butterflyBVM, PLUSCompact Medical Inc.BTM2026-03-13
00860012073580butterflyBVM, READYCompact Medical Inc.BTM2026-03-13
44710810084629N/AGALEMED CORPORATIONBTM2026-03-05
44710810084667N/AGALEMED CORPORATIONBTM2026-03-05
44710810085770N/AGALEMED CORPORATIONBTM2026-03-05
44710810119116N/AGALEMED CORPORATIONBTM2026-03-05
34026704923893RUSCHTELEFLEX INCORPORATEDBTM2026-02-18
24026704923773RUSCHTELEFLEX INCORPORATEDBTM2026-02-13
24026704923780RUSCHTELEFLEX INCORPORATEDBTM2026-02-13
24026704923797RUSCHTELEFLEX INCORPORATEDBTM2026-02-13
20885632467353HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632467360HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632467377HALYARDOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632490719HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632490740HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632490757HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
20885632490764HalyardOWENS & MINOR DISTRIBUTION, INC.BTM2026-01-29
05707480152568Ambu® SPUR® II Pediatric ResuscitatorAmbu A/SBTM2024-02-22
05707480145393SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13
05707480145416SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13
05707480145430SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13
05707480145454SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13
05707480145478SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13
05707480145492SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13
05707480145515SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13
05707480145539SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13
05707480145553SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13
05707480145577SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13
05707480145591SPUR® II Adult ResuscitatorAmbu A/SBTM2021-04-13