FDA.report

Medline Industries, Inc.

Primary DI
40080196521143
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
CPRM1126FP
Catalog number
CPRM1126FP
Device description
RESUSCITATOR,MAN.ADLT,TUBE,FILTER,PEEP
Published
2015-10-15
Public version status
Update
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
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications

CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196521143PackageGS16In Commercial Distribution
10080196521142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019652114340080196521143
1008019652114210080196521142

GMDN Terms

TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Sterilization Methods

Method

Contacts

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
true
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 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
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