FDA.reportPublic FDA data

Vital Signs

Primary DI
70885403255214
Brand
Vital Signs
Company
Carefusion Finland 320 Oy
Model
8000063
Catalog number
8000063
Device description
Low Dead Space Adapter, 5.0 mm
Published
2016-09-14
Public version status
Update
Distribution status
Not 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
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790312000ENDOTRACHEAL TUBE W/HOLDER & CONNECTORRespiratory Support Products, Inc.1979-02-21BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70885403255214PrimaryGS10
10885403255212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7088540325521470885403255214
1088540325521210885403255212

GMDN Terms#

Term, Definition table
TermDefinition
Pin-indexed adaptor, single-useA connecting device designed to join two incompatible devices/components through a system of uniquely coded pins, slots, or holes which match when united, and provide security against the inadvertent coupling of devices other than a specific pair. The device is often used to connect an anaesthetic agent container to its dedicated vapourizer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefu
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com

Regulatory Flags#

DUNS number
367919120
Device count
10
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403252051Multi-Link2052104-0052052104-0052016-09-14
10885403252068Multi-Link2052104-0062052104-0062016-09-14
10885403252075Multi-Link2052104-0072052104-0072016-09-14
10885403252082Multi-Link2052104-0082052104-0082016-09-14
10885403252112Multi-Link2052133-0052052133-0052016-09-14
10885403252129Multi-Link2052133-0062052133-0062016-09-14
10885403252136Multi-Link2052133-0072052133-0072016-09-14
10885403252143Multi-Link2052133-0082052133-0082016-09-14
10885403256837Multi-Link2086349-0032086349-0032016-09-14
10885403256844Multi-Link2086349-0042086349-0042016-09-14
10885403256875Multi-Link2086367-0032086367-0032016-09-14
10885403256882Multi-Link2086367-0042086367-0042016-09-14
10885403417436Multi-Link2052104-0272052104-0272016-09-14
10885403417450Multi-Link2052133-0272052133-0272016-09-14
10190752100015Multi-Link™2090101-0502090101-0502017-07-11
10190752100022Multi-Link™2090101-0602090101-0602017-07-11
10190752100046Multi-Link™2090101-0802090101-0802017-07-11
10190752100084Multi-Link™2090101-5112090101-5112017-07-11
10190752100107Multi-Link™2090101-5122090101-5122017-07-11
10190752100121Multi-Link™2090101-5132090101-5132017-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003750822KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750839KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750846KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750853ENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750860KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750877KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750884KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750891KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750907KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750709KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750716KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750723KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750730KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750747KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750754KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750761KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750778KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750785KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750792KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750808KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750815KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-07
00810003750495KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750501KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750518KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750525KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750532KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750549KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750556KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750563KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750570KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01