FDA.report

Welch Allyn, Inc.

Primary DI
00732094344745
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901044
Catalog number
30502-214UNO
Device description
BP CUFF NEO-5 2-TUBE SOFT W CLAMP
Published
2021-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DQXWire, guide, catheter
DXQblood pressure cuff

Product Code Classifications

CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
DXQBlood Pressure CuffCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094346435Direct MarkingGS10
00732094344745PackageGS140In Commercial Distribution
00732094344738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094346435007320943464357320943464350732094346435
00732094344745007320943447457320943447450732094344745
00732094344738007320943447387320943447380732094344738

GMDN Terms

TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags

DUNS number
198227881
Device count
1
DM exempt
false
Premarket exempt
false
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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00732094360370Welch Allyn, Inc.901144XSCRIBE-6AA-ACAAA2026-02-03
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00732094358957Welch Allyn, Inc.901203C360KIT95MXTBWLJBP2025-11-24
00732094358971Welch Allyn, Inc.901203C360KIT95CXTBWLJBP2025-11-24
00732094358988Welch Allyn, Inc.901203C360KIT95CXTBMBJX2025-11-24
00732094237740Welch Allyn, Inc.901049CP150A2025-09-22
00732094356366Welch Allyn, Inc.9010069293-046-572025-09-22
00732094356373Welch Allyn, Inc.9010069293-046-552025-09-22
00732094356380Welch Allyn, Inc.9010069293-046-062025-09-22
00732094356397Welch Allyn, Inc.9010069293-046-052025-09-22
00732094356403Welch Allyn, Inc.9010069293-046-042025-09-22
00732094356410Welch Allyn, Inc.9010069293-046-032025-09-22
00732094309225Welch Allyn, Inc.90105744XT2021-04-26
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