FDA.reportPublic FDA data

DOUBLE INSUFFLATION BULB

Primary DI
04053755125999
Brand
DOUBLE INSUFFLATION BULB
Company
Heine Optotechnik GmbH & Co. KG
Model
000
Catalog number
E-000.18.105
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCMEndoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCMEndoscope, RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053755125999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053755125999040537551259994053755125999

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope inflation bulbA device that is used in conjunction with an endoscope and its direct application and which assists in the use of the endoscope. It is a dedicated device shaped as a rubber bulb which is used to feed air via the endoscope to obtain an endoscopic view of the site. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1 (603) 742-7103service@heine-na.com

Regulatory Flags#

DUNS number
315274563
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053755203567BETA X VET OPHTHALMOSCOPE000G-140.28.3302026-03-31
04053755203574BETA X VET OTOSCOPE000G-130.28.3302026-03-31
04053755207541XV4 BETA X VET SPECULUM4 MMG-000.21.3202026-03-31
04053755207558XV6 BETA X VET SPECULUM6 MMG-000.21.3212026-03-31
04053755207565X CHANGE SYSTEM SL-MAGNIFIER 000G-000.21.2202026-03-31
04053755180172HEINE SIGMA®250000C-008.33.3402016-09-24
04053755180738HEINE SIGMA®250000C-008.33.3412016-09-24
04053755202690DELTA 30 UV002026-03-02
04053755203314DELTA XLEDK-130.28.3302025-12-03
04053755203321DELTA X CPP00K-000.34.2372025-12-03
04053755203338DELTA X CPG00K-000.34.2382025-12-03
04053755202904BETA X Otoscope3xB-130.28.3302025-07-18
04053755202911BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755202744BETA X Otoscope4.2 xB-131.28.3302025-07-18
04053755203031BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755202973FINOFF TRANSILLUMINATOR2,5 VC-001.17.0802025-07-17
04053755202966BETA X OPHTHALMOSCOPELEDC-130.28.3302025-07-17
04053755203048GAMMA 3.2000M-000.09.9472025-07-17
04053755202928DELTAoneBLACK WHITE EDITIONK-214.28.3052025-04-30
04053755136988GAMMA 3.1000M-000.09.9412022-12-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842180187597ELMEDELMED INCORPORATEDGCM2024-04-09
00842180185685ELMEDELMED INCORPORATEDGCM2024-02-20
04055207062890PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062906PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062913PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062920PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062937PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04055207062944PANOVIEW ULTRARichard Wolf GmbHGCM2021-05-25
04042761083485OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
04042761083492OlympusOLYMPUS Winter & Ibe GmbHGCM2020-07-31
04953170393112DVI CABLE 3MOLYMPUS MEDICAL SYSTEMS CORP.GCM2020-05-27
04055207065761NARichard Wolf GmbHGCM2020-05-06
00842180136014ELMEDELMED INCORPORATEDGCM2019-04-30
00842180135970ELMEDELMED INCORPORATEDGCM2019-04-22
00842180135932ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135949ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135956ELMEDELMED INCORPORATEDGCM2019-04-15
00842180135963ELMEDELMED INCORPORATEDGCM2019-04-15
04055207011652NARichard Wolf GmbHGCM2017-07-21
04055207058015NARichard Wolf GmbHGCM2017-07-21
04055207058022NARichard Wolf GmbHGCM2017-07-21
04055207058039NARichard Wolf GmbHGCM2017-07-21