3100B HFOV

Primary DI
00198843006324
Brand
3100B HFOV
Company
Zoll Medical Corporation
Model
29028-016-40
Device description
3100B Disposables Kit, Box of 4 / F&P 850
Published
2026-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LSZVentilator, High Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSZVentilator, High FrequencyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890057000MODEL 3100 FREQUENCY OSCILLATORY VENTILATORZOLL Medical Corporation1991-03-29LSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10198843006321PackageGS14In Commercial Distribution
00198843006324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019884300632110198843006321
00198843006324001988430063241988430063240198843006324

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Regulatory Flags#

DUNS number
055363428
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
true
Expiration date on label
true
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
001988430062703100B HFOV11744-850K-402026-08-26
001988430062943100A HFOV29028-003-402026-08-26
001988430063003100A HFOV29028-004-402026-08-26
001988430063623100 HFOV11437-PMN-402026-08-26
00847946030926ZENIX8900-000421-012026-08-26
00198843003606Infant Flow™777010-402026-08-14
00198843003613Infant Flow™777012-402026-08-14
00198843003620Infant Flow™777014-402026-08-14
00198843003637Infant Flow™777016-402026-08-14
00198843003644Infant Flow™777018-402026-08-14
00198843003651Infant Flow™777020-402026-08-14
00198843003668Infant Flow™777022-402026-08-14
00198843003675Infant Flow™777024-402026-08-14
00198843003682Infant Flow™777026-402026-08-14
00198843003699Infant Flow™777028-402026-08-14
10847946030954ZENIX8900-000390-012026-08-14
00198843002913bellavista301.114.000-402026-07-22
00198843002920bellavista302.323.000-402026-07-22
00198843006614ZENIX8116-12-41-02000-00-USA2026-07-21
00198843006621ZENIX1116-100047-21-USA-02026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
001988430062703100B HFOVZoll Medical CorporationLSZ2026-08-26
001988430062943100A HFOVZoll Medical CorporationLSZ2026-08-26
001988430063003100A HFOVZoll Medical CorporationLSZ2026-08-26
001988430063623100 HFOVZoll Medical CorporationLSZ2026-08-26
101907521553123100A HFOVVYAIRE MEDICAL, INC.LSZ2025-07-16
201907522010613100A HFOVVYAIRE MEDICAL, INC.LSZ2025-07-16
101907522010193100 HFOVVYAIRE MEDICAL, INC.LSZ2024-11-05
101907522007463100A HFOVVYAIRE MEDICAL, INC.LSZ2024-08-12
101907522007603100A HFOVVYAIRE MEDICAL, INC.LSZ2024-08-12
101907522015763100A HFOVVYAIRE MEDICAL, INC.LSZ2024-08-12
101907521488403100A/B HFOVVYAIRE MEDICAL, INC.LSZ2021-11-08
501907521599123100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-16
501907521551053100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551123100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551293100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551363100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521551433100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521554883100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521589843100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521590043100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
501907521597453100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-07
101907521588013100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
101907521588183100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
101907521588253100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521551503100B HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521552593100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521552663100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554263100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554333100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05
501907521554573100A HFOVVYAIRE MEDICAL, INC.LSZ2021-05-05