FDA.report

Vyaire

Primary DI
14250892903009
Brand
Vyaire
Company
Vyaire Medical GmbH
Model
V-892900
Catalog number
V-892900
Device description
Nose clip
Published
2019-03-19
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

Contact Domains

Product Codes

CodeName
BXJClip, Nose

Product Code Classifications

CodeDeviceSpecialtyClass
BXJClip, NoseAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14250892903009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1425089290300914250892903009

GMDN Terms

TermDefinition
Nose clip, single-useA device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function (e.g., spirometry), and/or to stop nosebleeds (epistaxis). It is typically constructed of plastic with rubber or foam tips. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+499314972127support.rt.eu.jae@vyaire.com

Regulatory Flags

DUNS number
329769991
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

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14250892906680Vyaire36-MFA105036-MFA10502021-09-24
14250892906697Vyaire36-MFA101036-MFA10102021-09-24
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14250892907021JaegerJaeger Medical GmbHBXJ2025-06-02
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00817081028331Disposable Blue PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2025-02-25
00817081028218PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2025-02-20
00840117321991Resp-O2 PFM Nose Clips, Adult / Pediatric Dynarex CorporationBXJ2024-10-21
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05030267161201NOSE CLIPIntersurgical IncorporatedBXJ2022-08-30
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00817081026832Noseclip, Disposable , Blue, Rubber PadA-M SYSTEMS, LLCBXJ2020-09-01
30641043500006Nose ClipMERCURY ENTERPRISES, INC.BXJ2020-08-04
00817081026757Noseclip, Disposable , White, Foam PadA-M SYSTEMS, LLCBXJ2020-08-03
00817081026290Noseclip, Disposable , White, Rubber PadA-M SYSTEMS, LLCBXJ2020-04-02
50190752144949AirLife™VYAIRE MEDICAL, INC.BXJ2020-01-17
00817081022704Disposable Blue PFT Nose Clip with Rubber PadsA-M SYSTEMS, LLCBXJ2019-10-28
00817081022728Disposable Blue PFT Nose Clip with Foam PadsA-M SYSTEMS, LLCBXJ2019-10-28
00817081022469Disposable PFT Nose Clip with Rubber PadsA-M SYSTEMS, LLCBXJ2019-10-25