FDA.report

Breathing bag set with PEEP valve, disposable

Primary DI
04049098000468
Brand
Breathing bag set with PEEP valve, disposable
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
MU04776
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
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
04049098000468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049098000468040490980004684049098000468

GMDN Terms

TermDefinition
Transport infant incubatorAn electrically-powered unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature; it is typically on wheels and also designed for transporting infants either outside or within the healthcare facility. It typically consists of a clear removable plastic hood with a mattress and operates using mains electricity (AC-powered) when not in use for transportation. During transport, it is connected to an ambulance electrical outlet or is battery-powered from a battery pack.

Sterilization Methods

Method

Contacts

PhoneEmail
+18004372437info@draeger.com

Regulatory Flags

DUNS number
788289952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04049098041829Disposable Mechanical Ventilation CircuitMU047712025-12-10
04048675673408Gateway Software Server VF9.0.1MS405452025-02-19
04048675762256Gateway Software Server VF9.1.137347182025-02-19
04048675777762Gateway Software Server VF9.1.237363762025-02-19
04048675780212Infinity R50-S RecorderMS412172025-02-19
04049098001519Infinity M300 Bedside ChargerMS295582025-02-19
04049098007061Infinity Gateway USB DongleMS117002025-02-19
04049098095730Infinity M300+MS339502025-02-19
04049098095778SHIP UNIT M300+MS336482025-02-19
04049098096423SHP EXC M300+MS336592025-02-19
04049098099264S/W SUB VF9.0 GatewayMS400462025-02-19
04049098099608Gateway Software Server VF9.0MS400482025-02-19
04049098099042Babyroo TN300 Infant Radiant WarmerMU203002023-06-08
04049098002035 INFINITY M300 Nellcor WPA2 MS260762015-10-24
04049098002066Infinity M300 Masimo WPA2 MS260312015-10-24
04049098002172Omega-S SolutionMS254902015-11-02
04049098003858Infinity Vista XL MonitorMS189862015-10-24
04049098003865INFINITY GAMMMA XLMS189852015-10-24
04049098004022Vista MonitorMS188542015-10-24
04049098004039Infinity Kappa MonitorMS188532015-10-24

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