Jumbo intubation tube

GUDID 03700620600549

Tracheal intubation tube dia 14,60/13,60 length 26cm, color coded white

EFER ENDOSCOPY

Rigid bronchoscope

Primary Device ID	03700620600549
NIH Device Record Key	3078178a-d9c7-4941-8d5f-cfef5e373076
Commercial Distribution Status	In Commercial Distribution
Brand Name	Jumbo intubation tube
Version Model Number	BT2800-3
Company DUNS	286097451
Company Name	EFER ENDOSCOPY
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700620600549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K854414

FDA Product Code

EOQ	Bronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

[03700620600549]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-11-03
Device Publish Date	2023-10-26

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04250302227209 - Optical grasping forceps	2023-11-22 Optical grasping forceps for BX-5500FA bronchial endoscope - 2 mobile jaws / head diameter 3 mm / working length 47 cm
04250302227216 - Optical stent removal forceps	2023-11-22 Optical stent removal forceps for BX-5500FA bronchial endoscope - 1 mobile jaw / head diameter 4 mm / working length 47 cm
04250302227223 - Optical biopsy forceps	2023-11-22 Optical biopsy forceps for BX-5500FA bronchial endoscope - 2 mobile jaws / head diameter 4 mm / working length 47 cm
G006DJ40431621 - Sterilization basket	2023-11-22 Basket with lid for sterilization of pediatric endoscope (External dimensions: 460 x 80 x 52 mm)
G006DJ4046SPEC927 - Sterilzation basket with lid	2023-11-22 Basket with lid for sterilization of adult endoscopes (External dimensions: 640 x 150 x 77 mm)
G006DJ4371178 - Sterilization basket with lid	2023-11-22 Basket for sterilization with lid and without silicone mat (External dimensions: 280 x 145 x 50 mm)
G006DJ45611715 - Sterilization basket without lid	2023-11-22 Basket for sterilization without lid and without silicone mat (External dimensions: 540 x 250 x 50 mm)

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