FDA.report

BF

Primary DI
40026072023455
Brand
BF
Company
Allied Medical, LLC
Model
64049
Device description
MASK,ADULT,W/O TUBING,50/CS
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40026072023455PackageGS150In Commercial Distribution
00026072023457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
4002607202345540026072023455
00026072023457000260720234570260720234570026072023457

GMDN Terms

TermDefinition
Oxygen administration kitA collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119066872
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00026072012406PC11-02-00382024-11-05
00026072012536PC11-02-10302024-11-05
00026072012550PC11-02-50412024-11-05
00026072012567PC11-02-50432024-11-05
00026072012604PC11-10-00072024-11-05
00026072012611PC11-10-00082024-11-05
00026072012659PC11-10-00182024-11-05
00026072012680PC11-10-00322024-11-05
00026072012697PC11-10-00332024-11-05
00026072012741PC11-10-00432024-11-05
00026072012789PC11-10-00482024-11-05
00026072013977PC11-01-00052024-11-05
00026072013991PC11-01-00092024-11-05
00026072014103PC11-01-00712024-11-05
00026072014134PC11-01-01132024-11-05
00026072014257PC11-03-00082024-11-05
00026072014356PC11-10-00852024-11-05
00026072014363PC11-10-00862024-11-05
00026072014387PC11-13-00072024-11-05
00026072014752PC12-01-42002024-11-05

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07045432120509Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
20885632467407HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467414HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467469HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
07045432115987The BAG Mask size 1Laerdal Medical ASBYG2026-01-14
07045432115994The BAG Mask size 2 Laerdal Medical ASBYG2026-01-14
07045432116007The BAG Mask size 3 Laerdal Medical ASBYG2026-01-14
07045432116014The BAG Mask size 4Laerdal Medical ASBYG2026-01-14
07045432116021The BAG Mask size 5Laerdal Medical ASBYG2026-01-14
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