FDA.reportPublic FDA data

Curaplex

Primary DI
00818834028011
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-C1500S
Catalog number
301-C1500S
Device description
Curaplex Select Resuscitation Bag, Adult, #5 Mask, 7 ft Oxygen Tubing, Reservoir, Handle, Standard Connector
Published
2017-12-05
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

Product Codes#

Code, Name table
CodeName
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021442000OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIROemedic International, Inc.2002-07-30BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818834028011PackageGS110In Commercial Distribution
00818834027984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818834028011008188340280118188340280110818834028011
00818834027984008188340279848188340279840818834027984

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
010712461
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818834028417Curaplex301-0903301-09032020-11-30
00818834028837MiiS Horus Endoscope Display System -Video BoxEVS 7002025-08-12
00812574026481Curaplex301-P3002EA2017-02-06
00818834028608Curaplex301-12218301-122182024-03-10
00818834028615Curaplex301-44F10-120301-44F10-1202024-03-10
00818834028622Curaplex301-44F50-100301-44F50-1002024-03-10
00818834028639Curaplex301-12218301-122182024-03-10
00818834028646Curaplex301-44F10-120301-44F10-1202024-03-10
00818834028684Curaplex301-44F50-100301-44F50-1002024-03-10
00818834028448Curaplex301-PrO2LT301-PrO2LT2024-01-10
00818834028455Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2024-01-10
00818834028462Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2024-01-10
00818834028479Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2024-01-10
00818834028486Curaplex301-PrO2LTEZ301-PrO2LTEZ2024-01-10
00818834028493Curaplex301-PrO2LT-FM301-PrO2LT-FM2024-01-10
00818834028509Curaplex301-PrO2LT-0301-PrO2LT-02024-01-10
00818834028516Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2024-01-10
00812574026221Curaplex301-005-100102017-02-06
00812574025064Curaplex301-005-100102017-12-22
00818834020466Curaplex301-180U301-180U2019-02-10

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