FDA.report

Curaplex

Primary DI
00812277035339
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
301-BVM300
Catalog number
2442-BVM300
Device description
Curaplex BVM, Infant, Mask Size 0 and 1, Universal Connector, 7FT O2 Tubing, Pop-Off Valve
Published
2019-08-30
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

Product Codes

CodeName
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications

CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812277035339PackageGS110In Commercial Distribution
00812277035292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812277035339008122770353398122770353390812277035339
00812277035292008122770352928122770352920812277035292

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Do not get wet.

Sterilization Methods

Method

Regulatory Flags

DUNS number
070556204
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 DIBrandModelCatalogPublished
00199972000085Curaplex8600-015358600-015352026-01-23
00199972000092Curaplex8600-015368600-015362026-01-23
00199972000108Curaplex8600-015378600-015372026-01-23
00199972000115Curaplex8600-015388600-015382026-01-23
00199972000122Curaplex8600-015398600-015392026-01-23
00199972000139Curaplex8600-015408600-015402026-01-23
00199972000146Curaplex8600-015418600-015412026-01-23
00199972000153Curaplex8600-015428600-015422026-01-23
00199972000160Curaplex8600-015438600-015432026-01-23
00199972000177Curaplex8600-015448600-015442026-01-23
00199972000184Curaplex8600-015458600-015452026-01-23
00199972000191Curaplex8600-015468600-015462026-01-23
00199972000207Curaplex8600-01546B8600-01546B2026-01-23
00199972000214Curaplex8600-015478600-015472026-01-23
00199972000221Curaplex8600-015488600-015482026-01-23
00199972000238Curaplex8600-015498600-015492026-01-23
00199972000016Curaplex Advanced Hemostatic Gauze4in x 4in (10cm x 10cm)CAHG-4X42025-12-17
00199972000030Curaplex Advanced Hemostatic Gauze3in x 1.6 Yds (7.6cm x 150 cm)CAHG-R52025-12-17
00199972000054Curaplex Advanced Hemostatic Gauze3in x 3.2Yds (7.6cm x 300 cm)CAHG-Z102025-12-17
00199972000078Curaplex®8600-015558600-015552025-12-17

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44710810084667N/AGALEMED CORPORATIONBTM2026-03-05
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34026704923893RUSCHTELEFLEX INCORPORATEDBTM2026-02-18
24026704923773RUSCHTELEFLEX INCORPORATEDBTM2026-02-13
24026704923780RUSCHTELEFLEX INCORPORATEDBTM2026-02-13
24026704923797RUSCHTELEFLEX INCORPORATEDBTM2026-02-13
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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
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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