FDA.reportPublic FDA data

Puritan Bennett

Primary DI
10884521145153
Brand
Puritan Bennett
Company
Covidien LP
Model
10086042
Device description
Rechargeable Lithium Ion Battery
Published
2021-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, continuous, facility use
MOXBatteries, rechargeable, for class 2 devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2
MOXBatteries, rechargeable, for class 2 devices

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193056000Puritan Bennett 980 Series Ventilator SystemCovidien, LLC2020-11-20CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521145153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452114515310884521145153

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder or container intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. It is typically used during a transport situation (e.g., a neonatal incubator), or when the device is designed to power a cordless devices (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521783829LigaSureMRASILF192026-10-23
10884521853812Shiley1108602026-10-25
10884521853829Shiley1108652026-10-25
10884521853836Shiley1108702026-10-25
10884521853843Shiley1108752026-10-25
10884521853850Shiley1108802026-10-25
10884521853867Shiley1108852026-10-25
10884521853874Shiley1108902026-10-25
10884521856547Touch SurgeryMDS300282026-10-23
10884521861114Vital SyncVITALSYNCSW032026-10-25
10884521039902Surgipro llVPF-703-MX2015-09-02
10884521063433Ti-CronX-11362015-09-02
10884521073951Versaport PlusNB8STF2016-09-24
10884521195677Surgipro IIVP-653-MX2015-09-02
10884521546349Surgipro IIVP86X2016-09-24
10884521701991MonosofCN793G2017-10-10
10884521702073Surgipro IIVP746XG2017-10-10
10884521702172SurgiproCP41G2017-10-10
10884521705173SurgiproSP690G2017-06-23
10884521171534Nellcor10005941-SG2022-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814747025239Novaplus Full Face AAV Non Vented Mask, Extra LargeSLEEPNET, CORP.CBK2026-10-23
00814747025246Novaplus Full Face AAV Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025253Novaplus Full Face AAV Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025260Novaplus Full Face AAV Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
00814747025277Novaplus Full Face Non Vented Mask, Extra LargeSLEEPNET, CORP.CBK2026-10-23
00814747025284Novaplus Full Face Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025291Novaplus Full Face Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025307Novaplus Full Face Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
00198843006454LTVZoll Medical CorporationCBK2026-09-18
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00198843002869bellavistaZoll Medical CorporationCBK2026-07-10
00198843002876bellavistaZoll Medical CorporationCBK2026-07-06
00198843001145bellavistaZoll Medical CorporationCBK2026-06-24
00198843001152bellavistaZoll Medical CorporationCBK2026-06-24
00848530108816Breathing CircuitSunset Healthcare Solutions, Inc.CBK2026-04-17
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06