FDA.reportPublic FDA data

Patient Circuit

Primary DI
04942962603867
Brand
Patient Circuit
Company
ATOM MEDICAL CORPORATION
Model
60386
Catalog number
60386
Published
2015-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTLVentilator, Emergency, Powered (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14942962603864PackageGS15In Commercial Distribution
04942962603867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1494296260386414942962603864
04942962603867049429626038674942962603867

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen therapy systemAn assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter15Millimeter

Contacts#

Phone, Email table
PhoneEmail
+81 488533661hitoshi.hayashi@atomed.co.jp

Regulatory Flags#

DUNS number
690632047
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04942962613057V-707 with Power Pack(100-120V)61305613052016-09-21
04942962610858V-2200 Infant Incubator 61085610852024-10-29
04942962616102Neo-Servo i Atom Infant Incubator Model 10261610616102024-10-29
04942962674065V-2100G Advanced Infant Incubator 67406674062024-10-29
04942962603058Oxygen Sensor For V-80860305603052016-09-21
04942962603171Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR60317603172016-09-21
04942962608619Semi-Iris Access Port Cover(20 pcs/pkg)60861608612016-09-21
04942962615228V-808 Main Unit Only(120 V)61522615222016-09-21
04942962603706BILI-THERAPY Pad Type60370603702016-09-21
04942962603713Pad(L) For BILI-THERAPY Pad Type60371603712016-09-21
04942962603720Pad(S) For BILI-THERAPY Pad Type60372603722016-09-21
04942962603737Pad Cover(L) For BILI-THERAPY Pad Type(50 pcs/box)60373603732016-09-21
04942962603744Pad Cover(S) For BILI-THERAPY Pad Type(50 pcs/box)60374603742016-09-21
04942962603874Neo Cot HL Stand60387603872016-09-21
04942962261227Mattress Sheet for Neo Cot(5 pcs/pkg)26122261222016-10-28
04942962603218Mattress Sheets(5 pcs/pkg)60321603212016-09-21
04942962602983Test Bag, 50mL60298602982015-10-23
04942962603553Dispo Liner, 500mL For S401D, Suction Canister(30 pcs/box)60355603552016-09-21
04942962603621Resusci Flow Rail mounting type60362603622016-09-21
04942962603638Resusci Flow w/Blender/Rail mounting type60363603632016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10887709145907PneupacICU MEDICAL, INC.BTL2025-12-04
10887709145914PneupacICU MEDICAL, INC.BTL2025-12-04
30887709145901PneupacICU MEDICAL, INC.BTL2025-12-04
30887709145918PneupacICU MEDICAL, INC.BTL2025-12-04
M68970110HMU020SAVe II+ Simplified Automated VentilatorSafeguard US Operating, LLCBTL2025-11-20
04048675686712VentStar Resus heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
04048675686736VentStar AutoBreath heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
04048675686729VentStar Resus heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
04048675686743VentStar AutoBreath heated (N)Drägerwerk AG & Co. KGaABTL2025-05-14
00850071887242Emergent RespiratoryMDL Solutions IncorporatedBTL2025-04-05
M6892500301010SAVeII+ Starter Bundle, 3-Patient – BasicSafeguard US Operating, LLCBTL2025-02-26
M6892501001010SAVeII+ Starter Bundle, 10-Patient – BasicSafeguard US Operating, LLCBTL2025-02-26
00637320061239VORTRAN GO2VENT® with Peep ValveVORTRAN MEDICAL TECHNOLOGY 1, INCBTL2025-02-20
M68970111HUS010SAVe II+ Simplified Automated VentilatorSafeguard US Operating, LLCBTL2024-12-17
10641043913161Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
10641043913352Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
10641043913659Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
30641043913165Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
30641043913356Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
30641043913653Neo-Tee T-Piece Resuscitator CircuitMERCURY ENTERPRISES, INC.BTL2024-02-08
00851629008072SAVe II+Automedx, LLCBTL2024-01-06
10851629008079SAVe II+Automedx, LLCBTL2024-01-06
20851629008076SAVe II+Automedx, LLCBTL2024-01-06
90851629008075SAVe II+Automedx, LLCBTL2024-01-06
07898671250175OXYMAGMAGNAMED TECNOLOGIA MEDICA SABTL2023-12-06
10889483231739VentlabVENTLAB, LLCBTL2023-07-18
10889483231746VentlabVENTLAB, LLCBTL2023-07-18
10889483231760VentlabVENTLAB, LLCBTL2023-07-18
10889483231777VentlabVENTLAB, LLCBTL2023-07-18