FDA.report

MEDLINE

Primary DI
20197344100467
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
CPRM4416PWM
Catalog number
CPRM4416PWM
Device description
RESUS,MAN,ADT,MASK,BAG,PEEP ATTACH,MANO
Published
2024-12-05
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
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications

CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344100467PackageGS16In Commercial Distribution
10197344100460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734410046720197344100467
1019734410046010197344100460

GMDN Terms

TermDefinition
Pulmonary resuscitator, manual, reusableA 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 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 reusable device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-18 Degrees Celsius51 Degrees Celsius
Special Storage Condition, Specify00NA
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

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
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

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20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
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