FDA.reportPublic FDA data

Nellcor

Primary DI
20884522042816
Brand
Nellcor
Company
Covidien LP
Model
FOAM P/I
Device description
Pediatric-Infant Foam Sensor Wrap; For use with Product Codes OXI-P/I and D-YS
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape and bandage, adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884522042816PackageGS12In Commercial Distribution
40884522042810PackageGS150In Commercial Distribution
10884522042819PrimaryGS10
50884522042817Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452204281620884522042816
4088452204281040884522042810
1088452204281910884522042819
5088452204281750884522042817

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric hospital bedA mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
50
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
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521091986NellcorSC-A-I2026-05-25
20884521841724Shiley50FXLTCP2026-03-17
20884521841687Shiley50FXLTCD2026-03-16
20884521841694Shiley60FXLTCD2026-03-16
20884521841700Shiley70FXLTCD2026-03-16
20884521841717Shiley80FXLTCD2026-03-16
20884521841731Shiley60FXLTCP2026-03-16
20884521841748Shiley70FXLTCP2026-03-16
20884521841755Shiley80FXLTCP2026-03-16
20884521841762Shiley50FXLTUD2026-03-16
20884521841779Shiley60FXLTUD2026-03-16
20884521841786Shiley70FXLTUD2026-03-16
20884521841793Shiley80FXLTUD2026-03-16
20884521841809Shiley50FXLTUP2026-03-16
20884521841816Shiley60FXLTUP2026-03-16
20884521841823Shiley70FXLTUP2026-03-16
20884521841830Shiley80FXLTUP2026-03-16
30884521841844Shiley50FXLTIN2026-03-16
20884521841854Shiley60FXLTIN2026-03-16
20884521841861Shiley70FXLTIN2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628942588907Blistape Blistape IncKGX2026-03-10
00628942588983Blistape Blistape IncKGX2026-03-10
60041260026852KrogerKROGER CO., THEKGX2026-03-09
00819143026354HealquHealqu LLCKGX2026-03-05
00819143026453HealquHealqu LLCKGX2026-03-05
00861092002644Cealogic FilmRECIBIO, INC.KGX2026-03-01
50192253049815TelfaCardinal Health 200, LLCKGX2026-02-25
50192253050088TelfaCardinal Health 200, LLCKGX2026-02-25
30197344181654CURADMEDLINE INDUSTRIES, INC.KGX2026-02-23
00819143026309HealquHealqu LLCKGX2026-02-19
05715205000360Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205000407Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205000438Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205000469Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205100015Plum QuickSoftPlum Safety ApSKGX2026-02-17
05715205110014Plum QuickSoftPlum Safety ApSKGX2026-02-17
05715205120013Plum QuickSoftPlum Safety ApSKGX2026-02-17
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