EOlife Charger

Primary DI
03770016085076
Brand
EOlife Charger
Company
ARCHEON
Model
A0000063
Device description
EOlife Charger (ref: A0000063) it the charger of the final device EOlife (AUS00055)
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K221841000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221841000EOlife®Archeon2023-03-18BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770016085076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770016085076037700160850763770016085076

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
270625868
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770016085021EOlife BPA00000232023-07-27
03770016085052EOlife ECUAUS000042023-07-27
13770016085011FlowSenseA00000472023-07-27
13770016085066EOlifeAUS000552023-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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