FDA.reportPublic FDA data

AVANOS

Primary DI
10609038968671
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
96867
Catalog number
11000
Device description
Ballard* Manual Percussor for Neonates
Published
2020-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYIPERCUSSOR, POWERED-ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYIPercussor, Powered-ElectricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K860510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K860510000NEONATE PERCUSSORBallard Medical Products1986-02-20BYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609038968674PrimaryGS10
10609038968671Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609038968674006090389686746090389686740609038968674
1060903896867110609038968671

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
12
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
false
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
00193493001088SINGLE SHOT EPIDURAL TRAY120008532182A2732026-08-21
00350770006840CORTRAK* Enteral Access System120008508P20-09502026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable Cable12000625220-09662026-08-21
00350770009094CORTRAK* Enteral Access System12000890420-09502026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable Cable12000887220-09662026-08-21
00350770007557CORFLO* Safety PEG Kit12000866230-53202026-08-14
00350770008868NEOMED* Oral / Enteral Syringe with ENFit® Connector120004764BA-S05NC2026-08-15
00350770008875NEOMED* Oral / Enteral Syringe with ENFit® Connector120004831BA-S12NC2026-08-15
00350770008899NEOMED* Oral / Enteral Syringe with ENFit® Connector120004839BA-S60NC2026-08-15
00350770008912NEOMED* Oral / Enteral Syringe with ENFit® Connector120004765BP-S05NC2026-08-15
00350770008929NEOMED* Oral / Enteral Syringe with ENFit® Connector120004842BP-S12NC2026-08-15
00350770008943NEOMED* Oral / Enteral Syringe with ENFit® Connector120004847BP-S60NC2026-08-15
00350770008967NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004849NEO122026-08-15
00350770008981NEOMED* At Home Oral / Enteral Syringe with ENFit® Connector120004852NEO602026-08-15
00350770009001NEOMED* Oral / Enteral Syringe with ENFit® Connector120004832BA-S12NC-S2026-08-15
00350770009018NEOMED* Oral / Enteral Syringe with ENFit® Connector120004869PNM-S12NC2026-08-15
00350770009032NEOMED* Oral / Enteral Syringe with ENFit® Connector120004874PNM-S35NC2026-08-15
00812120004895Game Ready* System120008544550500-042026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, Medium120008563590923-042026-07-31
00812120005113Game Ready* Ankle Wrap, Large120008549590330-042026-07-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841470100841PercussorPULMODYNE INCBYI2026-05-29
00841470100858PercussorPULMODYNE INCBYI2026-05-29
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00816305024920AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024937AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025101AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025248AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025255AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025262AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025279AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025286AffloVestTactile Systems Technology, Inc.BYI2026-05-27
10889483563113BALLARD™SUNMED, LLCBYI2025-12-01
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00606959420540inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420557inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420564inCourage®Respiratory Technologies, Inc.BYI2025-09-17
00606959420571inCourage®Respiratory Technologies, Inc.BYI2025-09-17
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07290020062024LibAirty Airway Clearance System Vest (M)SYNCHRONY MEDICAL LTDBYI2025-05-19
07290020062031LibAirty Airway Clearance System Vest (L)SYNCHRONY MEDICAL LTDBYI2025-05-19
B102125003S0110SmartVestELECTROMED, INC.BYI2025-03-19
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