FDA.reportPublic FDA data

BERRCOM

Primary DI
16947656115836
Brand
BERRCOM
Company
Guangzhou Berrcom Medical Device Co., Ltd
Model
NC007
Published
2024-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KMAIrrigator, Powered Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMAIrrigator, Powered NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16947656115836PackageGS140In Commercial Distribution
06947656115839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694765611583616947656115836
06947656115839069476561158396947656115839

GMDN Terms#

Term, Definition table
TermDefinition
Nasal aspirator, electricA portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It consists of a handgrip that contains the batteries, a small electric pump that creates the suction, and typically has a silicone nozzle attached to a detachable, washable, collection cup at the distal end. It is designed for domestic use and is typically applied superficially the nasal opening (i.e., not inserted into the nasal cavity). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529391821
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947656114658BerrcomAOJ-70C2026-04-22
06947656117932BERRCOMJXB-1832026-01-21
06947656118014BerrcomJXB-1782026-01-21
06947656118021DedeksDT1192026-01-21
06947656118038DedeksDT1162026-01-21
06947656118045DedeksDT1132026-01-21
06947656118052BERRCOMET1022026-01-21
56947656117937BERRCOMJXB-1832026-01-21
36947656118015BerrcomJXB-1782026-01-21
66947656118023DedeksDT1192026-01-21
66947656118030DedeksDT1162026-01-21
66947656118047DedeksDT1132026-01-21
46947656118050BERRCOMET1022026-01-21
06947656112951OlangdaJXB-1782025-10-13
06947656112968OlangdaJXB-1822025-10-13
06947656114610BERRCOMNC0052025-10-13
06947656115143BERRCOMDT0052025-10-13
06947656115648BPET1082025-10-13
06947656115655BPET1082025-10-13
06947656112944COCOBEARJXB-1782025-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079671003Naväge Rhinosystems, Inc.KMA2026-02-23
00763000548797HydrodebriderMEDTRONIC XOMED, INC.KMA2026-02-14
00763000548803HydrodebriderMEDTRONIC XOMED, INC.KMA2026-02-14
00057475491505BIOS DiagnosticsThermor LtdKMA2026-01-19
10057475491502BIOS DiagnosticsThermor LtdKMA2026-01-19
06978785665131InhwRiorShenzhen Yuechuan trade Co., Ltd.KMA2025-12-08
00763000435905Hydrodebrider™MEDTRONIC XOMED, INC.KMA2025-11-22
16971919460449Medi GradeNingbo Albert Novosino Co.,Ltd.KMA2025-11-17
06947656114610BERRCOMGuangzhou Berrcom Medical Device Co., LtdKMA2025-10-13
00892773001168SinuPulseHealth Solutions Medical Products CorporationKMA2025-08-28
06978785665063InhwRiorShenzhen Yuechuan trade Co., Ltd.KMA2025-08-08
00850027492957NavägeRhinosystems, Inc.KMA2025-07-08
00805106849603XTREMEXtreme Personal Care Inc.KMA2025-04-20
00850044118793iHealthiHealth Labs Inc.KMA2024-12-10
00850044118847iHealthiHealth Labs Inc.KMA2024-11-18
10850044118844iHealthIHEALTH LAB INC.KMA2024-11-18
00850044118861iHealthiHealth Labs Inc.KMA2024-10-30
10850044118868iHealthIHEALTH LAB INC.KMA2024-10-30
00767056181533HealthSmartD-M-S HOLDINGS, INC.KMA2024-09-25
10767056181530HealthSmartD-M-S HOLDINGS, INC.KMA2024-09-25
00858492004958NavägeRhinosystems, Inc.KMA2024-06-20
00057475160517BIOS DiagnosticsThermor LtdKMA2024-06-17
10057475160514BIOS DiagnosticsThermor LtdKMA2024-06-17
06947656115839BERRCOMGuangzhou Berrcom Medical Device Co., LtdKMA2024-06-12
00810051084849GuruNanda Portable Nasal IrrigatorGurunanda, LLCKMA2024-03-11
00767056181526HealthSmartD-M-S HOLDINGS, INC.KMA2024-01-26
10767056181523HealthSmartD-M-S HOLDINGS, INC.KMA2024-01-26
00767056181472Health Smart Guangzhou Berrcom Medical Device Co., LtdKMA2024-01-16
10767056181479Health Smart Guangzhou Berrcom Medical Device Co., LtdKMA2024-01-16
06975983273021MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.KMA2024-01-10