FDA.reportPublic FDA data

BCI

Primary DI
35019517062179
Brand
BCI
Company
ICU MEDICAL, INC.
Model
124006
Published
2016-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTLVentilator, emergency, powered (resuscitator)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030803000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030803000PARAPAC 200D TRANSPORT, MODEL V200DPneupac , Ltd.2003-09-29BTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019517062179PrimaryGS10
15019517062175Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501951706217935019517062179
1501951706217515019517062175

GMDN Terms#

Term, Definition table
TermDefinition
PEEP valve, single-useA non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197272BivonaFT26FN70NSZ233N2026-07-23
10887709198392BivonaSU26GN80NZC083N2026-07-23
10887709198408BivonaZA26GN85NSC085N2026-07-23
10887709198750BivonaSZ26GN70ZSZ114N2026-07-23
10887709198873BivonaZU26GN75NSC099N2026-07-23
10887709198941BivonaZU26GN60NGF143N2026-07-23
10887709198958BivonaZU26GN55NGF144N2026-07-23
10887709199085BivonaFU26GN35NGF169N2026-07-23
10887709199092BivonaFT26GN35NGA089N2026-07-23
10887709199108BivonaFT26GN35NGE166N2026-07-23
10887709199115BivonaST26GN40NGF165N2026-07-23
10887709199146BivonaFT26GN55NGC172N2026-07-23
10887709199153BivonaFU26GN55NGC170N2026-07-23
10887709199160BivonaFT26GN50NGC171N2026-07-23
10887709199177BivonaFU26GN40NGA178N2026-07-23
10887709199184BivonaFU26GN55NSF173N2026-07-23
10887709199207BivonaST26GN50NSC177N2026-07-23
10887709199214BivonaFT26GN30NGF174N2026-07-23
10887709199221BivonaST26GN55NSC176N2026-07-23
10887709199238BivonaFT26GN40NGE175N2026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437025198559Ventrain®INTERNATIONAL EMERGENCY SERVICES SOCIEDAD LIMITADA.BTL2026-06-24
10641043508473Neo-Tee T-Piece ResuscitatorMERCURY ENTERPRISES, INC.BTL2026-03-26
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